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Madge E. Buus-Frank DNP, APRN-BC, FAAN
Neonatal Nurse Practitioner
EMAIL: Dr.Madge.Buus.Frank@gmail.com
Evolving Guidelines and Standards:
How Will We Apply The “New Rules” to Real
World Clinical Clinical Cases?
Let’s Take a Break
Please Return at
Gratitude to the Committee
For Our Super Heroes!
Disclosures
• I am the immediate past Executive Vice President and Director of Quality Improvement and Education.
• I will likely be talking about “off-label” use of medications and therapies – a common reality of neonatal
care.
• The facts and opinions expressed are my own.
• I am sharing some of work of friends, colleagues and mentors, with their permission, for which I am ever
grateful.
• And yes – Geisel is the Dr. Suess School of Medicine!
Disclosure . . .
Beware of Grandchildren
Interspersed Throughout
Slides WILL Be Posted . . .
After YOU Solve the Mystery Cases!
Permission to Use –
Should You Find This Session Helpful . . .
Please feel free to “steal shamelessly” and share the learning with your
colleagues and home team!
• My only 2 asks are that you:
• Fact check the materials and sources to assure accuracy.
• Include a small attribution to the original source the bottom of any slide you
use.
• Example
Slides Shared With Permission: Dr. Madge Buus-Frank. The Children’s Hospital at Dartmouth.
US Regional Variation
in Use of Neonatal Intensive Care
www.dartmouthatlas.org/Neonatal_Atlas_090419.pdf
VLBW Infants
Late Preterm Infants
Full-Term Infants
Think About How You
and Your Team
Might
Improve Outcomes and
Add VALUE!
Potentially Preventable NICU Admissions
PPNAs
The Busy Day Effect
Concept of “Capacity Strain”
Snowden JM, Kozhimanni KB, Muoto
I, Caughey AB, McConnell KJ. A
‘busy day” effect on perinatal
complications of delivery on
weekends: a retrospective study.
BMJ. 2017 Jan:26(1).
When You Hear . . .
We are Having a Very Busy Day
You Should Think . . .
• Maternal and neonatal complications increased on “high-
volume days”
• APGAR <7 low volume week day 11% vs. 29%
• Increased risk of SZ
• Need for NICU admission
• Prolonged maternal length of say
• Weekend delivery may compound this.
Do Extended Duty Hours Impact Neonatal and
Maternal Outcomes?
The influence of hours worked prior to delivery on maternal and neonatal outcomes:
a retrospective cohort study. Aiken CE, Aiden AR, Scott JG, Brockelsby J. Am J.
Obstet Gynecol 2016. Nov;215(5) 634.
• Risk of maternal hemorrhage
and cord pH of < 7.1 varied
by 30 to 40% within
12 hour shifts (p<0.05)
• Declining technical skills
• Slower reaction times
• Impaired decision-making
Is There a Weekend Effect?
Association between day of delivery and obstetric outcomes: observational study. Palmer, WL,
Bottl A, Avlin P. BMJ 2019.Nov 24;351.
Nationally we could save 770 perinatal deaths and 470
maternal infections / year . . .
IF weekend performance was consistent with weekday
performance.
Practicing Under the Influence of Fatigue
DUI vs. PUIF
The 15 / 50% Dissemination Rule
Even when we have good quality evidence and consensus
about best practices exists . . .
It takes ~15 years for the evidence to reach 50% of the
patients who would benefit!
Let’s Warm Up!
Mystery Case – Delivery Room Symptoms
• 21 yr-old mother from local college
• Unplanned pregnancy; no longer in relationship
• Excellent prenatal care; good nutrition and
weight gain
• Denise smoking, drugs, ETOH
• Infant presents in the delivery room with harsh
high-pitched cry, hypertonia, hyper-reflexia,
difficult to console
• NAS scoring initiated
• Mother vehemently denies any drug use . . .
• Drug screen comes back + for opiates /THC
Risks? Concerns? Early Care Priorities?
Use of E-Cigarettes Classified as an Epidemic
by the US Surgeon General
• Rapid Rise in Use
– Most commonly used tobacco product by youth since 2014
– 1 in 5 high school students
– 1 in 20 middle school students
• Vape-Related Lung Incidents
– 805 cases reported from 46 states and 2 territories as of September 24,
2019
– 12 Deaths in 10 states
– 69% males
– 62% 18 to 34 years old; median age 23
– 77% THC-containing product
What Exactly is In Vape Products?
• THC
• Vitamin F Acetate
– (often used topically; inhalation effects unknown);
Also have found other additives
• “cutting agents /dilutents
• Pesticides
• Opioids
• Poisons and other toxins
• Ultra-fine particles
• Flavorings linked to lung disease
• Volatile organic compounds
• Heavy metals (nickel, tin and lead)
Questions for Your History and Physical
Just asking about smoking no longer cuts it!
• E-cigarettes
• E-hookas
• Vape pens
• Tanking systems
• Mods
• Electronic Nicotine Delivery Systems (ENDS)
• Some even look like flash drives
CDC Educational Tool
Juul at School?
What is the Most Likely Agent Given the
Early Symptoms?
Translation Into Practice
Requires the Work of Teams . . .
Mystery Case
• 35 4/7 week Pregnancy G3; P2-3
• 4.5 kg male infant
• Mother with BMI of 43
• “Well controlled” gestational diabetes
• Pre-Existing HTN and on RX
• Otherwise uncomplicated pregnancy
• C-Birth for escalating BPs
• Challenging extraction; APGARs of 6 and 9
• Skin-to-skin in the delivery room
• Committed to exclusive breastfeeding
Risks? Concerns? Early Care Priorities?
The Plot Thickens
• Mother with excess surgery related blood loss
• Extended operative time to close the wound
• Infant’s first blood sugar at 3 hours of age was 35
• Glucose gel equivalent dose of 200 mg/kg was administered
What Should We Do Next?
• Blood sugar increased to 55
• Infant bathed
• Next blood sugar 44 . . . then 29; Repeating glucose gel;
• Consult NICU – evaluated by NNP
• Exam reassuring
• Good suck
• Room Temperature?
• Baby Temperature?
Case Resolution
Back to the Basics . . .
Lessons Learned
What could / should they have done differently?
Improving Admission Temperatures
And The Quest for Euthermia
When Should the First Bath Be Given?
And Why?
Retrospective
Pre: Post Study
Clinical Challenge:
• Initial bath completed by 2 hours
• Rate of exclusive breastfeeding was
low
• Intervention: Delay initial bath to at
least 12 hours
• Pre: 448 dyads / Post 548 post
• In-hospital exclusive breastfeeding
increased from 59% to 68%
Preer G1, Pisegna JM, Cook JT, Henri AM, Philipp BL.Delaying the bath
and in-hospital breastfeeding rates.
Breastfeed Med. 2013 Dec;8(6):485-90.Epub 2013 May 2.
• Of the infants, 702 met inclusion criteria.
• Pre 2.4 hours / Post 13.5 hours of life.
• In-hospital exclusive breastfeeding rates increased from 32.7% to 40.2%
(p<0.05) after the bath was delayed.
• Multivariate logistic regression analysis showed that infants born after
implementation of delayed bathing had odds of exclusive breastfeeding
39% greater than infants born prior to the intervention (adjusted odds ratio
[AOR]=1.39; 95% confidence interval [CI] 1.02, 1.91) and 59% greater odds
of near-exclusive breastfeeding (AOR=1.59; 95% CI 1.18, 2.15). The odds of
breastfeeding initiation were 166% greater for infants born after the
intervention than for infants born before the intervention (AOR=2.66; 95%
CI 1.29, 5.46).
Risks? Concerns? Early Care Priorities?
Neonatal Hypoglycemia – A 2.1 Billion
Dollar Problem!
• Common problem
• Primary risk factors
• LGA
• SGA
• IDM
• Late Preterm
• Affects 15% to 30% of all newborns
• 10% required “intensive” management = $2.1 Billion dollars
https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD011027.
pub2/full
Average cost per case decreased from $25K
to $9K Saved $429,000 over 8 months FY
2014
Data Courtesy of Rainbow Babies & Children
Example Slide Courtesy of Bianca Leonardi MD / Rainbow Babies and Childrens 2016
Full improvement story on the VON Learning Management System
Big Contributors to NICU Admissions Late
Preterm and LGA Infants
Diabetes Mellitus
Incidence
• 8% of all pregnancies
• 86% are gestational diabetes
• Maternal obesity, Family history of diabetes, > 40 yrs; Multiparity, previous
LGA, congenital abnl, hydramnios, stillbirth
Pathophysiology
• Estrogen, progesterone and human placental lactogen  resistance to
insulin
• Pancreas cannot meet needs
Diabetes Factoids
• 1 in 100 women have DB before pregnancy
• 3 to 8% develop gestational DB
• Women with GDB have 50% chance of developing diabetes later
in life
 Lowest risk is a BMI of 30–34.9
 Medium risk is a BMI of 35.0–39.9
 Highest risk is a BMI of >40.
Obesity Among Women of Childbearing Age
United States, 2007-2017
Source: Behavioral Risk Factor Surveillance System, Centers for Disease Control and Prevention. Retrieved October 8, 2019, from www.marchofdimes.org/peristats.
Unique Surgical Challenges and Patient
Safety Hazards
Diabetes in Pregnancy Associated with
an Increased Risk of
• In utero fetal demise / stillbirth
• C-Birth
• Preeclampisa (which may require early delivery for maternal
indications)
• Sleep apnea
NOTE: Some studies report a decreased risk of spontaneous preterm
birth!
Fetal Effects
• LGA
• Hypoglycemia
• Polycythemia
• Hyperviscocity
• Jaundice
• Hypocalcemia
• Hypomagnesemia
• Congenital malformations
• Birth trauma
Practice Pearls
•  risk for macrosomia 25% to 45%
• Shoulder dystocia, clavicular fracture, Erb’s palsy
• Overall mortality risk 30/1000 live births or 4X
normal
Poorly Controlled Pre-Existing Diabetes
http://en.wikibooks.org/wiki/Handbook_of_Genetic_Counseling/Diabetes_in_Pregnancy
Malformations most likely to originate before 7th week gestation:
• Congenital heart defects 5X risk
• Transposition of great vessels, VSD, ASD
• Situs inversus 84X risk
• Anal Rectal atresia 5X risk
• NTD 10X risk
• Anencephaly 5X risk
• Caudal regression syndrome 300X risk
• Renal 5X risk
• Agenesis 6 X risk
• Cystic kidney 4 X risk
• Ureter duplex 23 X risk
Practical Pearls
•In general more severe or uncontrolled DB the
 risk for poor outcomes
•IDDM and uncontrolled have 2 to 3X incidence of
congenital anomalies
•Birth defects occur in 6-8% in this class
•Gestational diabetes = much smaller  risk
If blood sugar levels are well
controlled beginning before
pregnancy, risk for complications
falls to almost equal to the
population risk!!!
Caudal Regression Syndrome vs. Sirenomelia:
A Case Report
http://www.nature.com/jp/journal/v22/n2/images/7210598f2.jpg
Multi-System Impact of Diabetes
Sharma D, Pandita A, Shastri S, Sharma P.
Asymmetrical septal hypertrophy and hypertrophic
cardiomyopathy in infant of diabetic mother:
A reversible cardiomyopathy.
Med J DY Patil Univ 2016;9:257-60
• Up to 30% develop Cardiomyopathy
• 5% develop CHF
• Outflow track obstruction and cardiac
ouput may be worsened by pressors
Echo May Be Useful!
Sharma D, Pandita A, Shastri S, Sharma P. Asymmetrical septal hypertrophy and
hypertrophic cardiomyopathy in infant of diabetic mother: A reversible cardiomyopathy. Med
J DY Patil Univ 2016;9:257-60
Transient Newborn Hypoglycemia –
A “Messy” Clinical Problem
• Lack of consensus on definitions of the
condition?
• Is it abnormal? Or not?
• Some purport it is a normal physiologic
trigger that promotes post-natal adaptation
• Ideal threshold of intervention to prevent
harm?
• What is the best timing of the first blood
glucose ?
• Where should these infants be cared for?
• Maternal infant separation impairs
lactogenesis and bonding
A QI Initiative to Reduce NICU Transfer for Neonatal at Risk of Hypoglycemia. LeBlan S, Haushalter J,
Seashore C, et. Al. Pediatrics. 20018 Mar;141(3).
• Infants >35 weeks gestation
• At least 1 risk factor for hypoglycemia
• Bundle for at risk infants implemented
• Reduced NICU transfer rate from 17% to 3% overall
• Percent infant admitted to NICU but did not require feedings
decreased from 5% to 0.7% overall
Upstream Thinking . . . Prevention of Hypoglycemia!
A QI Initiative to
Reduce NICU
Transfer for Neonatal
at Risk of
Hypoglycemia.
LeBlan S, Haushalter
J, Seashore C, et. Al.
Pediatrics. 20018
Mar;141(3).
Clinical Pearls
• Poor Breastfeeding rates are common among obese women
• 80% initiate breastfeeding
• <50% continue beyond 6 months
Also:
• Delayed lactogenesis
• Lower overall milk production
• Preterm birth / maternal infant separation
• High rates of post c-birth complications 50%
Data Obsesssion Runs in the Family
Process Measure Did They Follow Their Protocol?
Percent of Infants Receiving Skin-to-Skin Care in First 1 Hour of Life
A QI Initiative to Reduce NICU Transfer for Neonatal at Risk of Hypoglycemia. LeBlan S, Haushalter J, Seashore C,
et. Al. Pediatrics. 20018 Mar;141(3).
-1SD
-3SD
-2SD
+3SD
+2SD
+1SD
MEAN
68.3%
95.5%
99.7%
Proportion of data by SD (σ) in a normal distribution Standard Deviation
• SPC analog: Sigma (σ)
• avg. distance of data from mean
• how sigma calculated depends on type and
distribution of data – e.g.
SPCC Slides Courtesy of Dr. Mathew Niedner. With Permission.
-1SD
-3SD
-2SD
+3SD
+2SD
+1SD
MEAN
+1σ
+3σ
+2σ
-3σ
-2σ
-1σ
MEAN
 TIME 
LOWER CONTROL LIMIT (LCL)
UPPER CONTROL LIMIT (UCL)
Control Chart (Shewart Chart)
• Statistical Process Control (SPC)
• Graphical time-series analysis
SPCC Slides Courtesy of Dr. Mathew Niedner. With Permission.
+1σ
+3σ
+2σ
-3σ
-2σ
-1σ
MEAN
 TIME 
LOWER CONTROL LIMIT
UPPER CONTROL LIMIT
Understanding Variation in SPC
Common Cause
“noise”
Special Cause
“signal”
(the four conventional rules)
Any Point(s)
Beyond
Control Limits (3σ)
“Large Effect Size”
2 of 3 Consecutive Points
Beyond
2σ from Mean
4 of 5 Consecutive Points
Beyond
1σ from Mean
9 Consecutive Points
on Same Side
of Mean Line
“Small but sustained signal”
There are other numerous other criteria/rules for identifying special cause
• The more rules used, the more likely of false positive signals
• For example:
• Stairstepping: 6 successive points trending up or down
• Stratification: 15 consecutive points within +/-1 sigma of mean
Process Measure Did They Follow Their Protocol?
Percent of Infants Receiving Skin-to-Skin Care in First 1 Hour of Life
A QI Initiative to Reduce NICU Transfer for Neonatal at Risk of Hypoglycemia. LeBlan S, Haushalter J, Seashore C,
et. Al. Pediatrics. 20018 Mar;141(3).
Did They “Feed the Baby?”
Percent Asymptomatic At Risk Infants Fed in First 1 Hour of Life
A QI Initiative to Reduce NICU Transfer for Neonatal at Risk of Hypoglycemia. LeBlan S, Haushalter
J, Seashore C, et. Al. Pediatrics. 20018 Mar;141(3).
Did They Prevent Unnecessary NICU Admissions?
Percent Asymptomatic At Risk Infant Transferred to the NICU
Saved $2500 Per Infant $100,000 per year
More Evidence for Short-Term Efficacy . . .
Another Recent Glucose Gel Study
Makker K, Alissa R, Dudek C, Travers L, Smotherman C, Hudak M. Glucose Gel in Infants at Risk for Transitional Neonatal HypoglycemiaAm J Perinatol.
2018 Sep;35(11):1050-1056.
OBJECTIVE
• Evaluate whether glucose gel as a supplement to feedings in infants admitted to the NB nursery at risk for neonatal hypoglycemia
(NH) reduces the frequency of transfer to a higher level of care for intravenous dextrose treatment.
STUDY DESIGN
• Revised our newborn nursery protocol for management of infants at risk for NH
• Use of 40% glucose gel (200 mg/kg);
• Late preterm, SGA, LGA, and Late Preterm Infants
• We compared outcomes before (4/1/14-3/31/15: Year 1) and after (4/1/15-3/31/16: Year 2) initiation of the revised protocol.
PRIMARY OUCOME Transfer to the neonatal intensive care unit (NICU) for treatment with a continuous infusion of dextrose.
• NICU transfer for management of NH fell from 8.1% in Year 1 (34 of 421 at-risk infants screened) to 3.7% in Year 2 (14 of 383 at-
risk infants screened).
• Rate of exclusive breastfeeding increased from 6% in Year 1 to 19% in Year 2.
• Hospital charges for the study population decreased from $801,276 to $387,688 USD in Year 1 and Year 2, respectively.
CONCLUSION
• Our study supports the adjunctive use of glucose gel to reduce NICU admissions and total hospitalization expense.
The Jury is Still Out . . .
Puchalski ML, Russell TL, Karlsen KA. Neonatal Hypoglycemia: Is There a Sweet Spot?
Crit Care Nurs Clin North Am. 2018;30(4):467-480.
Mary reminds us that . . .
• Level of evidence is admittedly of a low to mid-range quality.
• Outcome measures are primarily focused on important “short-term”
gains;
• Unclear about the long-term impact on brains.
• Stay tuned for updated guidelines!
Clinical Pearls
IF you decide to use this agent . . .
Definitely is “off-label use.
Careful Administration
FEED THE BABY! Milk is a much
more “balanced” nutritional source.
Glucose gel is an adjunct therapy; it
does not replace the need for
feedings!
With permission: Sudha Rani Narasimhan, MD IBCLC
Director, Well Baby Nursery and Lactation
Santa Clara Valley Medical Center, San Jose, California, USA
Sudharani.Narasimhan@hhs.sccgov.org has provided Permission to Share at NANN
Quality Improvement to Reduce Mother-Infant
Separation and Antibiotics Use in Inborn
Infants >34 Weeks Gestation
SMART AIM
 To decrease mother-infant separation of newborns born
at >34 weeks GA from a baseline of 6% in 2008-2014 to
4% by 2018.
Mother-infant separation = NICU Admission
With permission: Sudha Rani Narasimhan, MD IBCLC
Key Driver Diagram
With permission: Sudha Rani Narasimhan, MD IBCLC
 Outcome
 Maternal Infant Separation: Defined as any infant admitted to the NICU
 Process
 NICU admission for sepsis evaluation
 Any antibiotic exposure
 Culture proven early onset sepsis
 Balancing
 Readmissions within 30 days with serious bacterial infection
Key Measures
With permission: Sudha Rani Narasimhan, MD IBCLC
N=25,416
With permission: Sudha Rani Narasimhan, MD IBCLC – Data Represents Infants > 34 weeks 2011 -2018 n+25,416 infants
N= 661
With permission: Sudha Rani Narasimhan, MD IBCLC – Data Represents Infants > 34 weeks 2011 -2018 n+25,416 infants
N= 661
With permission: Sudha Rani Narasimhan, MD IBCLC – Data Represents Infants > 34 weeks 2011 -2018 n+25,416 infants
NICU Beds Were Preserved For High-Acuity Admissions
With permission: Sudha Rani Narasimhan, MD IBCLC – Data Represents Infants > 34 weeks 2011 -2018 n+25,416 infants
New AAP GBS Guidelines
July 2019
“Separate consideration of infants born at ≥35 0/7 weeks’ gestation and
those born at ≤34 6/7 weeks’ gestation”
“The routine measurement of complete blood cell counts or
inflammatory markers such as C-reactive protein alone in newborn
infants to determine risk of GBS EOD is not justified given the poor test
performance of these in predicting what is currently a low-incidence
disease.86–89
“There is no evidence that hypoglycemia occurring in isolation in otherwise
well-appearing infants is a risk factor for GBS EOD or EOS.”
New AAP GBS Guidelines
July 2019
• Primary risk is maternal colonization ~ 20% to 30%
• Regional variations of 11% to 35%
• Colonization can be ongoing or intermittent
• Hence GBS NEGative means at that moment in time!
• Transmission is at / around the time of birth
• In the absence of IPA 50% of infants will be colonized
• Of those 1 to 2% will develop GBS Early Onset Disease
• Primary prevention strategy is Intra-Partum antibiotics for GBS + at time time of birth
and/or GBS UTI anytime during the pregnancy
• Antibiotics reach MIC at 2 to 4 hours and reach MIC in both mother and infant
• Neonatal colonization is prevented in 97% of the cases
New AAP GBS Guidelines
July 2019
• Categorical Assessment
• Multi-Variate Risk Assessment – Neonatal Early-Onset Sepsis Risk
Calculator
• https://neonatalsepsiscalculator.kaiserpermanente.org
• Risk Assessment Based Upon Infant’s Condition
Options for EOS risk assessment among infants born ≥35 weeks’ gestation.
Karen M. Puopolo et al. Pediatrics 2019;144:e20191881
©2019 by American Academy of Pediatrics
EOS risk assessment among infants born ≤34 weeks’ gestation. a Intraamniotic infection should be considered when
a pregnant woman presents with unexplained decreased fetal movement and/or there is sudden and unexplained
poor fetal testing. b Lumbar puncture...
Karen M. Puopolo et al. Pediatrics 2019;144:e20191881
©2019 by American Academy of Pediatrics
What About Low Risk Premature Infants?
• C-birth maternal indications like preeclampsia or poor fetal growth
• No labor or attempts to induce labor
• Intact membranes
• Fetal well-being
Acceptable initial approach?
(1) no laboratory evaluation and no empirical antibiotic therapy or
(2) blood culture and clinical monitoring.
For infants who do not improve after initial stabilization and/or those who
have severe systemic instability, the administration of empirical antibiotics
may be reasonable but is not mandatory.
Context Matters . . .
A Good Idea in One Unit May Not Work
or Be a Potential Dangerous Practice
in Another Setting
Sepsis Risk Calculator Website
• Clinical care algorithms
reflect current care at
Northern CA Kaiser-
Permanente birth
hospitals
• Threshold for blood
culture: >1/1000
• Threshold for antibiotics:
>3/1000
New website: http://neonatalsepsiscalculator.kaiserpermanente.org
Also reached at: http://kp.org/eoscalc
Kaiser Permanente Northern California (KPNC)
• Integrated healthcare system with 14 birth hospitals
• Common inpatient and outpatient electronic medical record
• All caregivers employed by KPNC
• Very high rate of prenatal care
• Infants born at a KPNC hospital covered for a minimum of 30 days,
regardless of the infant’s insurance status: therefore they can track
outcomes post-birth hospital discharge
With Permission: Dr. Karen Puopolo
Implementation at KPNC
• Baseline period
• EOS risk assessment based on CDC guidelines
• Learning period
• EOS calculator based only on sepsis risk at birth available for clinical use; no guidance was
given on how to use it
• EOS calculator period
• Newborn’s clinical presentation was incorporated into the final risk estimate, and care
recommendations were provided with the calculator
Kuzniewicz MW, et al. JAMA Pediatr 2017
With Permission: Dr. Karen Puopolo
Sepsis Risk Calculator at KPNC:
Decrease in EOS Evaluations and Antibiotics
Time Period Live Births
Blood Culture
≤ 24 hrs
Antibiotics ≤ 24
hrs
p-value
CDC guidelines
(1/2010-11/2012)
95,343
13,797
(14.5%)
4741
(5.0%)
-
EOS Calculator
(7/2014-10/2015)
56,261
2754
(4.9%)
1482
(2.6%)
<0.001
Kuzniewicz MW, et al. JAMA Pediatr 2017
With Permission: Dr. Karen Puopolo
Measures of Safety
Time Period
CDC Guidelines
Period
EOS Calculator
Period
Total Cases 24 (0.03%) 12 (0.02%)
Symptomatic at Birth 12 (50%) 6 (50%)
Critically Ill 2 1
Death 0 1*
Readmission ≤ 7 days
of life with EOS
5.2/100,00 5.3/100,000
*Infant with severe HIE treated with antibiotics, ECMO and cooling from birth
Slides Courtesy of Karen Puopolo. Used With Permission.
Kaiser-Permanente SRS Implementation
EOS Antibiotic Use Declined by 50%
With Permission: Dr. Karen Puopolo
Implementation Conclusions
• SRC can safely decrease the proportion of infants evaluated
and empirically treated for risk of EOS compared to prior
recommended approaches
• No evidence that infants presenting later in more advanced
state of illness
• Rate of re-hospitalization for EOS very low at baseline and not
different with use of SRC
Slides Courtesy of Karen Puopolo. Used With Permission.
Sepsis Evaluations / Well Appearing Newborns
Resources Quantified* US 2011 Dollars
Cost variable Cost (charge)$* Source
Physician Fees
 Infant requiring antibiotics
 Infant not requiring antibiotics
103.32
140.93
CPT codes 99221 and 99222
Nursing time “Costs” 29.25/hr - 57.78/hr
(input value average 45/hr)
personal communication
Cost of Ampicillin (4 doses) 19.52 (4.88 per pt per dose) Redbook ref (Average whole sale
price)
Gentamicin (2 doses) 3.44 (1.72 per pt per dose) Redbook ref (Average whole sale
price)
CBC & Differential (or repeats) 25.6 (64) Hospital lab charges
Blood culture 40 (84-110) Hospital lab charges
Positive culture sensitivity 22.4 (56) Hospital lab charges
IV restarts 0 NA
*2011 dollars
Mukhopadhyay, et al. Pediatrics 2014
EOS Evaluation & Therapy:
Resource Utilization
CDC 2010 based local protocol N = 476
Total triage hour, all evaluations 864 (123)
Median triage hours per patient (IQR)
• No antibiotics
• Antibiotics
1.8 (0.5–3.2)
• 0.7 (0.3–1.9)
• 2 (1.3–3.3)
Total cost for all evaluations $132,843 ($18,967)
Median total cost per patient (IQR) $292 ($164-$365)
Return visits to the ICU (% of total evaluated)
• No antibiotics
• Antibiotics
58 (12.2)
• 2 (0.4)
• 56 (11.8)
Extrapolation From the Well-Appearing Cohort
4 million births
• 11% preterm
• 3.56 million term infants
• 6.8% of evaluated and well-appearing (excludes all 3 cases symptomatic at presentation)
• 242,082 infants evaluated
• 435,744 hours
•$ 70,687,944 2011 US Dollars
• Primary risk is maternal colonization ~ 20% to 30%
• Regional variations of 11% to 35%
• Colonization can be ongoing or intermittent
• Hence GBS NEGative means at that moment in time!
• Transmission is at / around the time of birth
• In the absence of IPA 50% of infants will be colonized
• Of those 1 to 2% will develop GBS Early Onset Disease
• Primary prevention strategy is Intra-Partum antibiotics for GBS + at time time of birth
and/or GBS UTI anytime during the pregnancy
• Antibiotics reach MIC at 2 to 4 hours and reach MIC in both mother and infant
• Neonatal colonization is prevented in 97% of the cases
New AAP GBS Guidelines
New AAP GBS Guidelines
July 2019
Neonatal Risk
• Preterm Birth
• Duration of ROM – Ascending infection affects the fetal compartment
• Maternal Fever
• Maternal Age and Race – Black teen mother = highest risk both for
missed screening and for GBS EOD
• Prior GBS infection -
• OB Practices – Frequent exams, membrane sweeping, fetal
monitoring
Mystery Case:
A Very Precipitous Delivery
• Delivery attendance requested STAT
• 30 year-old female who just presented to OB in active labor and
with SROM and crowing.
DELIVERY HISTORY
• Baby “Annie” was depressed at birth; Effective BMV; not
breathing spontaneously ETT placed.
• APGARS 5/8
• To NICU at 7 minutes of life for ongoing care / evaluation
The Plot Thickens – Early History
• Mother appears healthy and states she has been “well”
• Smoker (12 cigarettes /day)
• Denies ETOH; prescription or illicit drug use
• 5 yr-old son alive and well; not currently in mother’s care
What else do you want to know?
What are you thinking?
The Plot Thickens – Early Course
• Well-formed female infant
• Ballard consistent with 32 Weeks gestation
• 1370 grams; OFC 26.5 cm; Length 38 cm
• Blood cultures obtained.
• Given HBIG (UK Hepatitis status)
• Blood cultures obtained.
• Ampicillin and Gentamicin started
• Infant clinically improving and extubated at 4 hours of age
• Had mild apnea / bradycardia
Other ID Concerns
• Hep B Status UK - given HBIG
• Blood cultures NEGative on DOL 2
• Antibiotics extended for 7-days based upon infant’s status and
course.
Other ID Screens
• Maternal Serology NEG
Figure 1
Copyright © 2019 by The National Association of Neonatal Nurses 111
Relevant CBC and Heme Findings
Copyright © 2019 by The National Association of Neonatal Nurses 112
Percutaneous Central Line Placed in
Response to Transient Hypoglycemia
and Feeding Intolerance
IF an Infant Presented With These Skin Findings . . . .
What Should You Be Thinking About Now?
Copyright © 2019 by The National Association of Neonatal Nurses 113
Imaging
• Head Ultrasound WNL
• Adrenal Ultrasound ? R-Sided Hemorrhage
20 Hours of Age
• Clinically quite jaundiced; bilirubin was 12.5 mg/dL
• Phototherapy initiated
• DOL 2 Direct bilirubin was also climbing to 5.7 mg/dL
• LFTs obtained; all WNL
Summarizing Our Clinical Picture
• SGA
• Thrombocytopenia
• Reticulocytosis
• Eye exam
• Hemolysis
• Direct Hyperbilirubinemia
• Hepatosplenomegaly
TORCH WORK-UP
• NEG chorioretinitis
• Elevated IGG CMV / and Herpes Maternal antibodies; NOT infant infection
• IGM for Toxo, CMV, Herpes and Parovirus NEG
Risks? Concerns? What Should We Do Next?
Pediatric ID Consult
 Mini-Metabolic Evaluation – Serum Amino Acids / Urine Organic
Acids
 Repeat CMV testing (urine and Buffy Coat)
 Urine for viral culture
 IGM / IGG syphilis (despite NL VDRL)
Case Resolution
Babies IGM Positive for Syphilis
Maternal RPR and FTA Positive on DOL 12
LP performed with NL cell count,
glucose, protein and VDRL NEG ruling
out meningitis.
Treated with 10 days of PCN;
hypothesized that her symptoms
did not progress further because of initial
7-days of Ampicillin.
Needs repeat LP at 6 months of age.
Important Lessons Learned
• Lack of prenatal care elevates risk.
• Early testing and treatment are effective in preventing; however, 1
in 3 affected got tested but either acquired syphilis after the
testing or were not treated
• Now recommending serial testing for women at high-risk
• Increased risk for co-infection with HIV
• Often key screens are missing or incomplete!
Newborn Syphilis Cases More Than Double
in 4 years reaching 20-Year High!
cdc.gov/media/releases/2018/p0925o-newborn-syphilis-caes.html
• Miscarriage
• Death
• Severe life-long physical and mental
complications
80% Transmission Rate
Fetal or perinatal death
rate is 40%
CDC 2017 Data
Regional Variation 37 States Reporting Cases
One Million Infections Every Day
With 1 of the 4 Common STDS!
chlamydia, neisseria
gonorrhoeae*,
syphilis and
trichmoniasis
Lessons Learned From This Case
With newly acquired or incubating
syphilis all
antibody tests are NEGATIVE.
THUS: RPR should be done early;
repeated at 28 weeks, and again
Repeated after birth.
Figure 4
Copyright © 2019 by The National Association of Neonatal Nurses 128
Figure 3
Copyright © 2019 by The National Association of Neonatal Nurses 129
Figure 7
Copyright © 2019 by The National Association of Neonatal Nurses 130
Figure 6
Copyright © 2019 by The National Association of Neonatal Nurses 131
Acknowledgement
Stacey Dagleish RNS, MN, NNP Presented this case at the Neonatal APN
Forum 2003 and was Awarded the “Case of the Year.”
And the . . . She promptly published it!
Dalgleish S, Premji S, Young S, Kamaluddeen, M. Adv Neonatal Care;
2004;4(2): 79-91. Case Report of an SGA Infant With Jaundice,
Hyperbilirubinemia, Hepatosplenomegaly, Thrombocytopenia and a
Negative VDRL.
So What Have You Learned Today?
You Can’t Just Throw Your Hands Up in the Air!
When You Go Home and Try to Change
Practice . . . Remember You Are NOT
Aiming for “Buy-In”
Beyond “Buy-In!
You Need to Encourage Your Team Members to
Drive the Bus of Improvement !

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Evolving Guidelines and Standards: How Will We Apply The “New Rules” to Real World Clinical Clinical Cases?

  • 1. Madge E. Buus-Frank DNP, APRN-BC, FAAN Neonatal Nurse Practitioner EMAIL: Dr.Madge.Buus.Frank@gmail.com Evolving Guidelines and Standards: How Will We Apply The “New Rules” to Real World Clinical Clinical Cases?
  • 2. Let’s Take a Break Please Return at Gratitude to the Committee For Our Super Heroes!
  • 3.
  • 4.
  • 5. Disclosures • I am the immediate past Executive Vice President and Director of Quality Improvement and Education. • I will likely be talking about “off-label” use of medications and therapies – a common reality of neonatal care. • The facts and opinions expressed are my own. • I am sharing some of work of friends, colleagues and mentors, with their permission, for which I am ever grateful. • And yes – Geisel is the Dr. Suess School of Medicine!
  • 6. Disclosure . . . Beware of Grandchildren Interspersed Throughout
  • 7. Slides WILL Be Posted . . . After YOU Solve the Mystery Cases! Permission to Use – Should You Find This Session Helpful . . . Please feel free to “steal shamelessly” and share the learning with your colleagues and home team! • My only 2 asks are that you: • Fact check the materials and sources to assure accuracy. • Include a small attribution to the original source the bottom of any slide you use. • Example Slides Shared With Permission: Dr. Madge Buus-Frank. The Children’s Hospital at Dartmouth.
  • 8. US Regional Variation in Use of Neonatal Intensive Care www.dartmouthatlas.org/Neonatal_Atlas_090419.pdf VLBW Infants Late Preterm Infants Full-Term Infants
  • 9. Think About How You and Your Team Might Improve Outcomes and Add VALUE!
  • 10. Potentially Preventable NICU Admissions PPNAs
  • 11.
  • 12.
  • 13.
  • 14. The Busy Day Effect Concept of “Capacity Strain”
  • 15. Snowden JM, Kozhimanni KB, Muoto I, Caughey AB, McConnell KJ. A ‘busy day” effect on perinatal complications of delivery on weekends: a retrospective study. BMJ. 2017 Jan:26(1).
  • 16. When You Hear . . . We are Having a Very Busy Day You Should Think . . . • Maternal and neonatal complications increased on “high- volume days” • APGAR <7 low volume week day 11% vs. 29% • Increased risk of SZ • Need for NICU admission • Prolonged maternal length of say • Weekend delivery may compound this.
  • 17. Do Extended Duty Hours Impact Neonatal and Maternal Outcomes? The influence of hours worked prior to delivery on maternal and neonatal outcomes: a retrospective cohort study. Aiken CE, Aiden AR, Scott JG, Brockelsby J. Am J. Obstet Gynecol 2016. Nov;215(5) 634. • Risk of maternal hemorrhage and cord pH of < 7.1 varied by 30 to 40% within 12 hour shifts (p<0.05) • Declining technical skills • Slower reaction times • Impaired decision-making
  • 18. Is There a Weekend Effect? Association between day of delivery and obstetric outcomes: observational study. Palmer, WL, Bottl A, Avlin P. BMJ 2019.Nov 24;351. Nationally we could save 770 perinatal deaths and 470 maternal infections / year . . . IF weekend performance was consistent with weekday performance.
  • 19. Practicing Under the Influence of Fatigue DUI vs. PUIF
  • 20.
  • 21. The 15 / 50% Dissemination Rule Even when we have good quality evidence and consensus about best practices exists . . . It takes ~15 years for the evidence to reach 50% of the patients who would benefit!
  • 22. Let’s Warm Up! Mystery Case – Delivery Room Symptoms • 21 yr-old mother from local college • Unplanned pregnancy; no longer in relationship • Excellent prenatal care; good nutrition and weight gain • Denise smoking, drugs, ETOH • Infant presents in the delivery room with harsh high-pitched cry, hypertonia, hyper-reflexia, difficult to console • NAS scoring initiated • Mother vehemently denies any drug use . . . • Drug screen comes back + for opiates /THC
  • 23. Risks? Concerns? Early Care Priorities?
  • 24. Use of E-Cigarettes Classified as an Epidemic by the US Surgeon General • Rapid Rise in Use – Most commonly used tobacco product by youth since 2014 – 1 in 5 high school students – 1 in 20 middle school students • Vape-Related Lung Incidents – 805 cases reported from 46 states and 2 territories as of September 24, 2019 – 12 Deaths in 10 states – 69% males – 62% 18 to 34 years old; median age 23 – 77% THC-containing product
  • 25. What Exactly is In Vape Products? • THC • Vitamin F Acetate – (often used topically; inhalation effects unknown); Also have found other additives • “cutting agents /dilutents • Pesticides • Opioids • Poisons and other toxins • Ultra-fine particles • Flavorings linked to lung disease • Volatile organic compounds • Heavy metals (nickel, tin and lead)
  • 26. Questions for Your History and Physical Just asking about smoking no longer cuts it! • E-cigarettes • E-hookas • Vape pens • Tanking systems • Mods • Electronic Nicotine Delivery Systems (ENDS) • Some even look like flash drives
  • 28. What is the Most Likely Agent Given the Early Symptoms?
  • 29. Translation Into Practice Requires the Work of Teams . . .
  • 30. Mystery Case • 35 4/7 week Pregnancy G3; P2-3 • 4.5 kg male infant • Mother with BMI of 43 • “Well controlled” gestational diabetes • Pre-Existing HTN and on RX • Otherwise uncomplicated pregnancy • C-Birth for escalating BPs • Challenging extraction; APGARs of 6 and 9 • Skin-to-skin in the delivery room • Committed to exclusive breastfeeding
  • 31. Risks? Concerns? Early Care Priorities?
  • 32. The Plot Thickens • Mother with excess surgery related blood loss • Extended operative time to close the wound • Infant’s first blood sugar at 3 hours of age was 35 • Glucose gel equivalent dose of 200 mg/kg was administered
  • 33. What Should We Do Next? • Blood sugar increased to 55 • Infant bathed • Next blood sugar 44 . . . then 29; Repeating glucose gel; • Consult NICU – evaluated by NNP • Exam reassuring • Good suck • Room Temperature? • Baby Temperature?
  • 35. Back to the Basics . . . Lessons Learned What could / should they have done differently?
  • 36. Improving Admission Temperatures And The Quest for Euthermia
  • 37. When Should the First Bath Be Given? And Why?
  • 38. Retrospective Pre: Post Study Clinical Challenge: • Initial bath completed by 2 hours • Rate of exclusive breastfeeding was low • Intervention: Delay initial bath to at least 12 hours • Pre: 448 dyads / Post 548 post • In-hospital exclusive breastfeeding increased from 59% to 68%
  • 39. Preer G1, Pisegna JM, Cook JT, Henri AM, Philipp BL.Delaying the bath and in-hospital breastfeeding rates. Breastfeed Med. 2013 Dec;8(6):485-90.Epub 2013 May 2. • Of the infants, 702 met inclusion criteria. • Pre 2.4 hours / Post 13.5 hours of life. • In-hospital exclusive breastfeeding rates increased from 32.7% to 40.2% (p<0.05) after the bath was delayed. • Multivariate logistic regression analysis showed that infants born after implementation of delayed bathing had odds of exclusive breastfeeding 39% greater than infants born prior to the intervention (adjusted odds ratio [AOR]=1.39; 95% confidence interval [CI] 1.02, 1.91) and 59% greater odds of near-exclusive breastfeeding (AOR=1.59; 95% CI 1.18, 2.15). The odds of breastfeeding initiation were 166% greater for infants born after the intervention than for infants born before the intervention (AOR=2.66; 95% CI 1.29, 5.46).
  • 40. Risks? Concerns? Early Care Priorities?
  • 41. Neonatal Hypoglycemia – A 2.1 Billion Dollar Problem! • Common problem • Primary risk factors • LGA • SGA • IDM • Late Preterm • Affects 15% to 30% of all newborns • 10% required “intensive” management = $2.1 Billion dollars https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD011027. pub2/full
  • 42. Average cost per case decreased from $25K to $9K Saved $429,000 over 8 months FY 2014 Data Courtesy of Rainbow Babies & Children
  • 43. Example Slide Courtesy of Bianca Leonardi MD / Rainbow Babies and Childrens 2016 Full improvement story on the VON Learning Management System
  • 44. Big Contributors to NICU Admissions Late Preterm and LGA Infants
  • 45. Diabetes Mellitus Incidence • 8% of all pregnancies • 86% are gestational diabetes • Maternal obesity, Family history of diabetes, > 40 yrs; Multiparity, previous LGA, congenital abnl, hydramnios, stillbirth Pathophysiology • Estrogen, progesterone and human placental lactogen  resistance to insulin • Pancreas cannot meet needs
  • 46. Diabetes Factoids • 1 in 100 women have DB before pregnancy • 3 to 8% develop gestational DB • Women with GDB have 50% chance of developing diabetes later in life  Lowest risk is a BMI of 30–34.9  Medium risk is a BMI of 35.0–39.9  Highest risk is a BMI of >40.
  • 47.
  • 48. Obesity Among Women of Childbearing Age United States, 2007-2017 Source: Behavioral Risk Factor Surveillance System, Centers for Disease Control and Prevention. Retrieved October 8, 2019, from www.marchofdimes.org/peristats.
  • 49. Unique Surgical Challenges and Patient Safety Hazards
  • 50. Diabetes in Pregnancy Associated with an Increased Risk of • In utero fetal demise / stillbirth • C-Birth • Preeclampisa (which may require early delivery for maternal indications) • Sleep apnea NOTE: Some studies report a decreased risk of spontaneous preterm birth!
  • 51. Fetal Effects • LGA • Hypoglycemia • Polycythemia • Hyperviscocity • Jaundice • Hypocalcemia • Hypomagnesemia • Congenital malformations • Birth trauma
  • 52. Practice Pearls •  risk for macrosomia 25% to 45% • Shoulder dystocia, clavicular fracture, Erb’s palsy • Overall mortality risk 30/1000 live births or 4X normal
  • 53. Poorly Controlled Pre-Existing Diabetes http://en.wikibooks.org/wiki/Handbook_of_Genetic_Counseling/Diabetes_in_Pregnancy Malformations most likely to originate before 7th week gestation: • Congenital heart defects 5X risk • Transposition of great vessels, VSD, ASD • Situs inversus 84X risk • Anal Rectal atresia 5X risk • NTD 10X risk • Anencephaly 5X risk • Caudal regression syndrome 300X risk • Renal 5X risk • Agenesis 6 X risk • Cystic kidney 4 X risk • Ureter duplex 23 X risk
  • 54. Practical Pearls •In general more severe or uncontrolled DB the  risk for poor outcomes •IDDM and uncontrolled have 2 to 3X incidence of congenital anomalies •Birth defects occur in 6-8% in this class •Gestational diabetes = much smaller  risk
  • 55. If blood sugar levels are well controlled beginning before pregnancy, risk for complications falls to almost equal to the population risk!!!
  • 56. Caudal Regression Syndrome vs. Sirenomelia: A Case Report http://www.nature.com/jp/journal/v22/n2/images/7210598f2.jpg
  • 58. Sharma D, Pandita A, Shastri S, Sharma P. Asymmetrical septal hypertrophy and hypertrophic cardiomyopathy in infant of diabetic mother: A reversible cardiomyopathy. Med J DY Patil Univ 2016;9:257-60 • Up to 30% develop Cardiomyopathy • 5% develop CHF • Outflow track obstruction and cardiac ouput may be worsened by pressors
  • 59. Echo May Be Useful! Sharma D, Pandita A, Shastri S, Sharma P. Asymmetrical septal hypertrophy and hypertrophic cardiomyopathy in infant of diabetic mother: A reversible cardiomyopathy. Med J DY Patil Univ 2016;9:257-60
  • 60. Transient Newborn Hypoglycemia – A “Messy” Clinical Problem • Lack of consensus on definitions of the condition? • Is it abnormal? Or not? • Some purport it is a normal physiologic trigger that promotes post-natal adaptation • Ideal threshold of intervention to prevent harm? • What is the best timing of the first blood glucose ? • Where should these infants be cared for? • Maternal infant separation impairs lactogenesis and bonding
  • 61. A QI Initiative to Reduce NICU Transfer for Neonatal at Risk of Hypoglycemia. LeBlan S, Haushalter J, Seashore C, et. Al. Pediatrics. 20018 Mar;141(3). • Infants >35 weeks gestation • At least 1 risk factor for hypoglycemia • Bundle for at risk infants implemented • Reduced NICU transfer rate from 17% to 3% overall • Percent infant admitted to NICU but did not require feedings decreased from 5% to 0.7% overall Upstream Thinking . . . Prevention of Hypoglycemia!
  • 62. A QI Initiative to Reduce NICU Transfer for Neonatal at Risk of Hypoglycemia. LeBlan S, Haushalter J, Seashore C, et. Al. Pediatrics. 20018 Mar;141(3).
  • 63.
  • 64.
  • 65. Clinical Pearls • Poor Breastfeeding rates are common among obese women • 80% initiate breastfeeding • <50% continue beyond 6 months Also: • Delayed lactogenesis • Lower overall milk production • Preterm birth / maternal infant separation • High rates of post c-birth complications 50%
  • 66. Data Obsesssion Runs in the Family
  • 67. Process Measure Did They Follow Their Protocol? Percent of Infants Receiving Skin-to-Skin Care in First 1 Hour of Life A QI Initiative to Reduce NICU Transfer for Neonatal at Risk of Hypoglycemia. LeBlan S, Haushalter J, Seashore C, et. Al. Pediatrics. 20018 Mar;141(3).
  • 68. -1SD -3SD -2SD +3SD +2SD +1SD MEAN 68.3% 95.5% 99.7% Proportion of data by SD (σ) in a normal distribution Standard Deviation • SPC analog: Sigma (σ) • avg. distance of data from mean • how sigma calculated depends on type and distribution of data – e.g. SPCC Slides Courtesy of Dr. Mathew Niedner. With Permission.
  • 69. -1SD -3SD -2SD +3SD +2SD +1SD MEAN +1σ +3σ +2σ -3σ -2σ -1σ MEAN  TIME  LOWER CONTROL LIMIT (LCL) UPPER CONTROL LIMIT (UCL) Control Chart (Shewart Chart) • Statistical Process Control (SPC) • Graphical time-series analysis SPCC Slides Courtesy of Dr. Mathew Niedner. With Permission.
  • 70. +1σ +3σ +2σ -3σ -2σ -1σ MEAN  TIME  LOWER CONTROL LIMIT UPPER CONTROL LIMIT Understanding Variation in SPC Common Cause “noise” Special Cause “signal” (the four conventional rules) Any Point(s) Beyond Control Limits (3σ) “Large Effect Size” 2 of 3 Consecutive Points Beyond 2σ from Mean 4 of 5 Consecutive Points Beyond 1σ from Mean 9 Consecutive Points on Same Side of Mean Line “Small but sustained signal” There are other numerous other criteria/rules for identifying special cause • The more rules used, the more likely of false positive signals • For example: • Stairstepping: 6 successive points trending up or down • Stratification: 15 consecutive points within +/-1 sigma of mean
  • 71. Process Measure Did They Follow Their Protocol? Percent of Infants Receiving Skin-to-Skin Care in First 1 Hour of Life A QI Initiative to Reduce NICU Transfer for Neonatal at Risk of Hypoglycemia. LeBlan S, Haushalter J, Seashore C, et. Al. Pediatrics. 20018 Mar;141(3).
  • 72. Did They “Feed the Baby?” Percent Asymptomatic At Risk Infants Fed in First 1 Hour of Life A QI Initiative to Reduce NICU Transfer for Neonatal at Risk of Hypoglycemia. LeBlan S, Haushalter J, Seashore C, et. Al. Pediatrics. 20018 Mar;141(3).
  • 73. Did They Prevent Unnecessary NICU Admissions? Percent Asymptomatic At Risk Infant Transferred to the NICU Saved $2500 Per Infant $100,000 per year
  • 74. More Evidence for Short-Term Efficacy . . . Another Recent Glucose Gel Study Makker K, Alissa R, Dudek C, Travers L, Smotherman C, Hudak M. Glucose Gel in Infants at Risk for Transitional Neonatal HypoglycemiaAm J Perinatol. 2018 Sep;35(11):1050-1056. OBJECTIVE • Evaluate whether glucose gel as a supplement to feedings in infants admitted to the NB nursery at risk for neonatal hypoglycemia (NH) reduces the frequency of transfer to a higher level of care for intravenous dextrose treatment. STUDY DESIGN • Revised our newborn nursery protocol for management of infants at risk for NH • Use of 40% glucose gel (200 mg/kg); • Late preterm, SGA, LGA, and Late Preterm Infants • We compared outcomes before (4/1/14-3/31/15: Year 1) and after (4/1/15-3/31/16: Year 2) initiation of the revised protocol. PRIMARY OUCOME Transfer to the neonatal intensive care unit (NICU) for treatment with a continuous infusion of dextrose. • NICU transfer for management of NH fell from 8.1% in Year 1 (34 of 421 at-risk infants screened) to 3.7% in Year 2 (14 of 383 at- risk infants screened). • Rate of exclusive breastfeeding increased from 6% in Year 1 to 19% in Year 2. • Hospital charges for the study population decreased from $801,276 to $387,688 USD in Year 1 and Year 2, respectively. CONCLUSION • Our study supports the adjunctive use of glucose gel to reduce NICU admissions and total hospitalization expense.
  • 75. The Jury is Still Out . . . Puchalski ML, Russell TL, Karlsen KA. Neonatal Hypoglycemia: Is There a Sweet Spot? Crit Care Nurs Clin North Am. 2018;30(4):467-480. Mary reminds us that . . . • Level of evidence is admittedly of a low to mid-range quality. • Outcome measures are primarily focused on important “short-term” gains; • Unclear about the long-term impact on brains. • Stay tuned for updated guidelines!
  • 76. Clinical Pearls IF you decide to use this agent . . . Definitely is “off-label use. Careful Administration FEED THE BABY! Milk is a much more “balanced” nutritional source. Glucose gel is an adjunct therapy; it does not replace the need for feedings!
  • 77.
  • 78. With permission: Sudha Rani Narasimhan, MD IBCLC Director, Well Baby Nursery and Lactation Santa Clara Valley Medical Center, San Jose, California, USA Sudharani.Narasimhan@hhs.sccgov.org has provided Permission to Share at NANN Quality Improvement to Reduce Mother-Infant Separation and Antibiotics Use in Inborn Infants >34 Weeks Gestation
  • 79. SMART AIM  To decrease mother-infant separation of newborns born at >34 weeks GA from a baseline of 6% in 2008-2014 to 4% by 2018. Mother-infant separation = NICU Admission With permission: Sudha Rani Narasimhan, MD IBCLC
  • 80. Key Driver Diagram With permission: Sudha Rani Narasimhan, MD IBCLC
  • 81.  Outcome  Maternal Infant Separation: Defined as any infant admitted to the NICU  Process  NICU admission for sepsis evaluation  Any antibiotic exposure  Culture proven early onset sepsis  Balancing  Readmissions within 30 days with serious bacterial infection Key Measures With permission: Sudha Rani Narasimhan, MD IBCLC
  • 82. N=25,416 With permission: Sudha Rani Narasimhan, MD IBCLC – Data Represents Infants > 34 weeks 2011 -2018 n+25,416 infants
  • 83. N= 661 With permission: Sudha Rani Narasimhan, MD IBCLC – Data Represents Infants > 34 weeks 2011 -2018 n+25,416 infants
  • 84. N= 661 With permission: Sudha Rani Narasimhan, MD IBCLC – Data Represents Infants > 34 weeks 2011 -2018 n+25,416 infants
  • 85. NICU Beds Were Preserved For High-Acuity Admissions With permission: Sudha Rani Narasimhan, MD IBCLC – Data Represents Infants > 34 weeks 2011 -2018 n+25,416 infants
  • 86. New AAP GBS Guidelines July 2019 “Separate consideration of infants born at ≥35 0/7 weeks’ gestation and those born at ≤34 6/7 weeks’ gestation” “The routine measurement of complete blood cell counts or inflammatory markers such as C-reactive protein alone in newborn infants to determine risk of GBS EOD is not justified given the poor test performance of these in predicting what is currently a low-incidence disease.86–89 “There is no evidence that hypoglycemia occurring in isolation in otherwise well-appearing infants is a risk factor for GBS EOD or EOS.”
  • 87. New AAP GBS Guidelines July 2019 • Primary risk is maternal colonization ~ 20% to 30% • Regional variations of 11% to 35% • Colonization can be ongoing or intermittent • Hence GBS NEGative means at that moment in time! • Transmission is at / around the time of birth • In the absence of IPA 50% of infants will be colonized • Of those 1 to 2% will develop GBS Early Onset Disease • Primary prevention strategy is Intra-Partum antibiotics for GBS + at time time of birth and/or GBS UTI anytime during the pregnancy • Antibiotics reach MIC at 2 to 4 hours and reach MIC in both mother and infant • Neonatal colonization is prevented in 97% of the cases
  • 88. New AAP GBS Guidelines July 2019 • Categorical Assessment • Multi-Variate Risk Assessment – Neonatal Early-Onset Sepsis Risk Calculator • https://neonatalsepsiscalculator.kaiserpermanente.org • Risk Assessment Based Upon Infant’s Condition
  • 89. Options for EOS risk assessment among infants born ≥35 weeks’ gestation. Karen M. Puopolo et al. Pediatrics 2019;144:e20191881 ©2019 by American Academy of Pediatrics
  • 90. EOS risk assessment among infants born ≤34 weeks’ gestation. a Intraamniotic infection should be considered when a pregnant woman presents with unexplained decreased fetal movement and/or there is sudden and unexplained poor fetal testing. b Lumbar puncture... Karen M. Puopolo et al. Pediatrics 2019;144:e20191881 ©2019 by American Academy of Pediatrics
  • 91. What About Low Risk Premature Infants? • C-birth maternal indications like preeclampsia or poor fetal growth • No labor or attempts to induce labor • Intact membranes • Fetal well-being Acceptable initial approach? (1) no laboratory evaluation and no empirical antibiotic therapy or (2) blood culture and clinical monitoring. For infants who do not improve after initial stabilization and/or those who have severe systemic instability, the administration of empirical antibiotics may be reasonable but is not mandatory.
  • 92. Context Matters . . . A Good Idea in One Unit May Not Work or Be a Potential Dangerous Practice in Another Setting
  • 93.
  • 94. Sepsis Risk Calculator Website • Clinical care algorithms reflect current care at Northern CA Kaiser- Permanente birth hospitals • Threshold for blood culture: >1/1000 • Threshold for antibiotics: >3/1000 New website: http://neonatalsepsiscalculator.kaiserpermanente.org Also reached at: http://kp.org/eoscalc
  • 95. Kaiser Permanente Northern California (KPNC) • Integrated healthcare system with 14 birth hospitals • Common inpatient and outpatient electronic medical record • All caregivers employed by KPNC • Very high rate of prenatal care • Infants born at a KPNC hospital covered for a minimum of 30 days, regardless of the infant’s insurance status: therefore they can track outcomes post-birth hospital discharge With Permission: Dr. Karen Puopolo
  • 96. Implementation at KPNC • Baseline period • EOS risk assessment based on CDC guidelines • Learning period • EOS calculator based only on sepsis risk at birth available for clinical use; no guidance was given on how to use it • EOS calculator period • Newborn’s clinical presentation was incorporated into the final risk estimate, and care recommendations were provided with the calculator Kuzniewicz MW, et al. JAMA Pediatr 2017 With Permission: Dr. Karen Puopolo
  • 97. Sepsis Risk Calculator at KPNC: Decrease in EOS Evaluations and Antibiotics Time Period Live Births Blood Culture ≤ 24 hrs Antibiotics ≤ 24 hrs p-value CDC guidelines (1/2010-11/2012) 95,343 13,797 (14.5%) 4741 (5.0%) - EOS Calculator (7/2014-10/2015) 56,261 2754 (4.9%) 1482 (2.6%) <0.001 Kuzniewicz MW, et al. JAMA Pediatr 2017 With Permission: Dr. Karen Puopolo
  • 98. Measures of Safety Time Period CDC Guidelines Period EOS Calculator Period Total Cases 24 (0.03%) 12 (0.02%) Symptomatic at Birth 12 (50%) 6 (50%) Critically Ill 2 1 Death 0 1* Readmission ≤ 7 days of life with EOS 5.2/100,00 5.3/100,000 *Infant with severe HIE treated with antibiotics, ECMO and cooling from birth Slides Courtesy of Karen Puopolo. Used With Permission.
  • 100. EOS Antibiotic Use Declined by 50% With Permission: Dr. Karen Puopolo
  • 101. Implementation Conclusions • SRC can safely decrease the proportion of infants evaluated and empirically treated for risk of EOS compared to prior recommended approaches • No evidence that infants presenting later in more advanced state of illness • Rate of re-hospitalization for EOS very low at baseline and not different with use of SRC Slides Courtesy of Karen Puopolo. Used With Permission.
  • 102. Sepsis Evaluations / Well Appearing Newborns Resources Quantified* US 2011 Dollars Cost variable Cost (charge)$* Source Physician Fees  Infant requiring antibiotics  Infant not requiring antibiotics 103.32 140.93 CPT codes 99221 and 99222 Nursing time “Costs” 29.25/hr - 57.78/hr (input value average 45/hr) personal communication Cost of Ampicillin (4 doses) 19.52 (4.88 per pt per dose) Redbook ref (Average whole sale price) Gentamicin (2 doses) 3.44 (1.72 per pt per dose) Redbook ref (Average whole sale price) CBC & Differential (or repeats) 25.6 (64) Hospital lab charges Blood culture 40 (84-110) Hospital lab charges Positive culture sensitivity 22.4 (56) Hospital lab charges IV restarts 0 NA *2011 dollars Mukhopadhyay, et al. Pediatrics 2014
  • 103. EOS Evaluation & Therapy: Resource Utilization CDC 2010 based local protocol N = 476 Total triage hour, all evaluations 864 (123) Median triage hours per patient (IQR) • No antibiotics • Antibiotics 1.8 (0.5–3.2) • 0.7 (0.3–1.9) • 2 (1.3–3.3) Total cost for all evaluations $132,843 ($18,967) Median total cost per patient (IQR) $292 ($164-$365) Return visits to the ICU (% of total evaluated) • No antibiotics • Antibiotics 58 (12.2) • 2 (0.4) • 56 (11.8)
  • 104. Extrapolation From the Well-Appearing Cohort 4 million births • 11% preterm • 3.56 million term infants • 6.8% of evaluated and well-appearing (excludes all 3 cases symptomatic at presentation) • 242,082 infants evaluated • 435,744 hours •$ 70,687,944 2011 US Dollars
  • 105. • Primary risk is maternal colonization ~ 20% to 30% • Regional variations of 11% to 35% • Colonization can be ongoing or intermittent • Hence GBS NEGative means at that moment in time! • Transmission is at / around the time of birth • In the absence of IPA 50% of infants will be colonized • Of those 1 to 2% will develop GBS Early Onset Disease • Primary prevention strategy is Intra-Partum antibiotics for GBS + at time time of birth and/or GBS UTI anytime during the pregnancy • Antibiotics reach MIC at 2 to 4 hours and reach MIC in both mother and infant • Neonatal colonization is prevented in 97% of the cases New AAP GBS Guidelines
  • 106. New AAP GBS Guidelines July 2019 Neonatal Risk • Preterm Birth • Duration of ROM – Ascending infection affects the fetal compartment • Maternal Fever • Maternal Age and Race – Black teen mother = highest risk both for missed screening and for GBS EOD • Prior GBS infection - • OB Practices – Frequent exams, membrane sweeping, fetal monitoring
  • 107. Mystery Case: A Very Precipitous Delivery • Delivery attendance requested STAT • 30 year-old female who just presented to OB in active labor and with SROM and crowing. DELIVERY HISTORY • Baby “Annie” was depressed at birth; Effective BMV; not breathing spontaneously ETT placed. • APGARS 5/8 • To NICU at 7 minutes of life for ongoing care / evaluation
  • 108. The Plot Thickens – Early History • Mother appears healthy and states she has been “well” • Smoker (12 cigarettes /day) • Denies ETOH; prescription or illicit drug use • 5 yr-old son alive and well; not currently in mother’s care What else do you want to know? What are you thinking?
  • 109. The Plot Thickens – Early Course • Well-formed female infant • Ballard consistent with 32 Weeks gestation • 1370 grams; OFC 26.5 cm; Length 38 cm • Blood cultures obtained. • Given HBIG (UK Hepatitis status) • Blood cultures obtained. • Ampicillin and Gentamicin started • Infant clinically improving and extubated at 4 hours of age • Had mild apnea / bradycardia
  • 110. Other ID Concerns • Hep B Status UK - given HBIG • Blood cultures NEGative on DOL 2 • Antibiotics extended for 7-days based upon infant’s status and course. Other ID Screens • Maternal Serology NEG
  • 111. Figure 1 Copyright © 2019 by The National Association of Neonatal Nurses 111 Relevant CBC and Heme Findings
  • 112. Copyright © 2019 by The National Association of Neonatal Nurses 112 Percutaneous Central Line Placed in Response to Transient Hypoglycemia and Feeding Intolerance
  • 113. IF an Infant Presented With These Skin Findings . . . . What Should You Be Thinking About Now? Copyright © 2019 by The National Association of Neonatal Nurses 113
  • 114. Imaging • Head Ultrasound WNL • Adrenal Ultrasound ? R-Sided Hemorrhage
  • 115. 20 Hours of Age • Clinically quite jaundiced; bilirubin was 12.5 mg/dL • Phototherapy initiated • DOL 2 Direct bilirubin was also climbing to 5.7 mg/dL • LFTs obtained; all WNL
  • 116. Summarizing Our Clinical Picture • SGA • Thrombocytopenia • Reticulocytosis • Eye exam • Hemolysis • Direct Hyperbilirubinemia • Hepatosplenomegaly TORCH WORK-UP • NEG chorioretinitis • Elevated IGG CMV / and Herpes Maternal antibodies; NOT infant infection • IGM for Toxo, CMV, Herpes and Parovirus NEG
  • 117. Risks? Concerns? What Should We Do Next?
  • 118. Pediatric ID Consult  Mini-Metabolic Evaluation – Serum Amino Acids / Urine Organic Acids  Repeat CMV testing (urine and Buffy Coat)  Urine for viral culture  IGM / IGG syphilis (despite NL VDRL)
  • 119. Case Resolution Babies IGM Positive for Syphilis Maternal RPR and FTA Positive on DOL 12 LP performed with NL cell count, glucose, protein and VDRL NEG ruling out meningitis. Treated with 10 days of PCN; hypothesized that her symptoms did not progress further because of initial 7-days of Ampicillin. Needs repeat LP at 6 months of age.
  • 120. Important Lessons Learned • Lack of prenatal care elevates risk. • Early testing and treatment are effective in preventing; however, 1 in 3 affected got tested but either acquired syphilis after the testing or were not treated • Now recommending serial testing for women at high-risk • Increased risk for co-infection with HIV • Often key screens are missing or incomplete!
  • 121.
  • 122. Newborn Syphilis Cases More Than Double in 4 years reaching 20-Year High! cdc.gov/media/releases/2018/p0925o-newborn-syphilis-caes.html • Miscarriage • Death • Severe life-long physical and mental complications 80% Transmission Rate Fetal or perinatal death rate is 40%
  • 123. CDC 2017 Data Regional Variation 37 States Reporting Cases
  • 124. One Million Infections Every Day With 1 of the 4 Common STDS! chlamydia, neisseria gonorrhoeae*, syphilis and trichmoniasis
  • 125.
  • 126.
  • 127. Lessons Learned From This Case With newly acquired or incubating syphilis all antibody tests are NEGATIVE. THUS: RPR should be done early; repeated at 28 weeks, and again Repeated after birth.
  • 128. Figure 4 Copyright © 2019 by The National Association of Neonatal Nurses 128
  • 129. Figure 3 Copyright © 2019 by The National Association of Neonatal Nurses 129
  • 130. Figure 7 Copyright © 2019 by The National Association of Neonatal Nurses 130
  • 131. Figure 6 Copyright © 2019 by The National Association of Neonatal Nurses 131
  • 132. Acknowledgement Stacey Dagleish RNS, MN, NNP Presented this case at the Neonatal APN Forum 2003 and was Awarded the “Case of the Year.” And the . . . She promptly published it! Dalgleish S, Premji S, Young S, Kamaluddeen, M. Adv Neonatal Care; 2004;4(2): 79-91. Case Report of an SGA Infant With Jaundice, Hyperbilirubinemia, Hepatosplenomegaly, Thrombocytopenia and a Negative VDRL.
  • 133.
  • 134. So What Have You Learned Today? You Can’t Just Throw Your Hands Up in the Air!
  • 135. When You Go Home and Try to Change Practice . . . Remember You Are NOT Aiming for “Buy-In”
  • 136. Beyond “Buy-In! You Need to Encourage Your Team Members to Drive the Bus of Improvement !