International conference «Actual approaches to the extremely preterm babies: International experience and Ukrainian realities» (Kyiv, Ukraine, March 5-6, 2013)

1. Regionalization of Perinatal Care:
US Experience
The International Neonatology Conference
March 5-6, 2013
Kiev, Ukraine
Ann R Stark, MD
Professor of Pediatrics
Vanderbilt University
Nashville, Tennessee, USA

3. US Infant, Neonatal, Postneonatal
Mortality Rates 1940-2006
Neonatal mortality: deaths < 28 days decreased from
28.8 to 4.5 per 1000 live births (85%); 4.04 in 2011
MMWR 2008; 57(14):377

4. Causes of Infant Death in US 2011
Causes (8 of top 10) %
Congenital malformations, deformations, 20.8
chromosomal abnormalities
Disorders related to short gestation and low BW 17.2
Newborn affected by pregnancy complications 6.6
Newborn affected by complications of placenta, 4.1
cord and membranes
Bacterial sepsis of newborn 2.2
Respiratory distress of newborn 2.1
Diseases of the circulatory system 2.1
Neonatal hemorrhage 1.9
Preliminary data Hamilton BE. Pediatrics 2013 ePub Feb 11

5. History of Regionalization in the US
• 1976 March of Dimes Committee on Perinatal
Health wrote Toward Improving the Outcome of
Pregnancy (TIOP I) - defined 3 levels of care in
context of a regionalized system
– Refer high-risk patients to centers with appropriate
resources and personnel
– Most Level III NICUs at academic centers
• 1993 TIOP II: Designations changed to Basic,
Specialty, Subspecialty with expanded criteria
• 1997, 2002 Guidelines for Perinatal Care retained
Basic, Specialty, and Subspecialty definitions

6. Problems with Previous Definitions
and Their Applications
• Definitions were too broad to define services
at an institution
• Perinatal classification (birth hospitals) did not
account for freestanding children’s hospitals
• Many states do not have specific regulations
defining levels of care; in those that do, many
do not enforce them
• Many institutions designate a level of care for
themselves

7. History - continued
• 2004 American Academy of Pediatrics
Committee on Fetus and Newborn developed
a policy statement on Levels of Neonatal Care
• General principles
– Newborns have a gradation of risk based on
gestational age and severity of illness
– Definitions should be based on the capabilities of
a neonatal unit to provide care appropriate for the
level of risk

8. Levels of Neonatal Care
• General principles – continued
– Each newborn should be delivered and cared for
in a facility most appropriate for his or her needs
– Further definitions of facility level should include
requirements for equipment, personnel, ancillary
services, training, and organization (including
transport)
AAP Committee on Fetus and Newborn. Levels of Neonatal Care 2004

9. Deregionalization of Neonatal
Intensive Care
• 15 year retrospective study of data from US
metropolitan areas 1980-1995
Increase (%)
Births 18
Hospitals with NICU beds 99
Neonatologists 268
Occupancy rates of NICUs 3
Howell EM. Am J Public Health 2002; 92:119

10. Neonatal Special Care Beds versus Births
US 1987-2008
Special care beds
89.2%
Births 14.6%
Source: Goodman DC N Engl J Med 2002;346:1538; 2009 AHA Survey

11. TIOP III: Regionalization Is Critical To
Improved Perinatal Outcomes
• Organizes a coordinated continuum
of perinatal services within a
geographic area
• Increases survival of high risk
newborns
• Concentrates relatively rare cases at a
few locations
• Centralizes expensive technologies
• Provides opportunities for clinical
teams to develop expertise
Toward Improving the Outcome of Pregnancy III, March of Dimes 2010

12. Preterm Infant Mortality is Increased by
Birth Outside of Level III Hospital
• Review of 41 US and non-US studies from 1976 to
2010 – 104,944 very low birthweight infants
• Risk of death is greater for infants born outside
of level III hospitals
– VLBW (< 1500 g) infants (37 studies)(38 vs 23%)
• OR 1.62, 95% CI 1.44-1.83
– ELBW (< 1000 g) infants (4 studies)
• OR 1.64 95% CI 1.14-2.36
– Very Preterm (≤32 weeks) infants (4 studies)
• OR 1.55, 95% CI 1.21, 1.98
• No changes over 30 year period
Lasswell S. JAMA 2010; 304:992

13. Extremely Low Birth Weight Mortality is Increased by
Birth Outside Level III Hospital (59 vs 32%)
Overall 1.80
Lasswell S. JAMA 2010;304:992

14. Major Morbidity is Higher in Outborn
Infants < 32 Weeks Gestation
Outcome Inborn (%) Outborn (%)
Death 9 16*
Severe (> grade 3) 7 17*
intraventricular hemorrhage
Chronic lung disease 16 22*
Patent ductus arteriosus 19 27*
Respiratory distress syndrome 48 79*
Late-onset infection 15 26*
Data from Canadian Neonatal Network p<0.05 Chein L-Y Obstet Gynecol 2001; 98:247

15. Other Factors May Affect Outcome
• NICU volume - experience
• Obstetric characteristics – antenatal steroids
• Nursing staff
• Race or health insurance status
• Surveillance – how do we measure?
• Approach to aggressive resuscitation
• Congenital anomalies – typically not counted
• Practice issues

16. Risk of VLBW Mortality by NICU Level and Annual Volume
NICU Level Volume Odds Ratio (95% CI)
1 <10 2.72 (2.37-3.13)*
>10 2.39 (1.91-3.00)*
2 <10 2.53 (2.02-3.18)*
11-25 1.88 (1.56-2.26)*
>25 1.22 (0.98-1.52)
3A <25 1.69 (1.28-2.24)*
26-50 1.78 (1.35-2.34)*
>50 1.08 (0.96-1.21)*
3B,3C, 3D 51-100 1.19 (1.04-1.37)*
>100 1.00 Reference
48,237 infants 1991-2000, no anomalies Phibbs CS N Engl J Med 2007; 356:2165

17. Very Low Birth Weight Delivery Volume Stronger
Influence on Mortality than Hospital Level of Care
Adjusted Odds Ratio for VLBW Mortality
Volume
Level
500-1499 g, no anomalies
California, 1997-2002 Chung JH. Med Care 2010; 48:635

18. Patient Volume Only Partly Explains
NICU Quality
Mean standardized mortality ratio
(observed/expected deaths) 94,110 VLBW infants born
in 332 Vermont-Oxford
Network hospitals with
NICUs, 1995-2000
Volume of admissions
explained only 9% of
variation in mortality
rates, 7% other factors
Rogowski J. JAMA. 2004;291(2):202-209. doi:10.1001/jama.291.2.202

19. Vermont Oxford Network Outcomes 2009
~58,000 Very Low Birth Weight infants in 812 NICUs NICU Percentiles
75
50 ●
●
% 25
● ●
●
● ●
CLD=Chronic lung disease; NEC=Necrotizing enterocolitis; IVH=
intraventricular hemorrhage; ROP= Retinopathy of prematurity

20. Center Differences in Treatment with Saline
and/or Vasopressor for Low Blood Pressure in
Extremely Low Birth Weight Infants
Lowest mean arterial pressure on 1st day (median)
%
mm
Hg
Center
Laughon M, et al. ELGAN study. Pediatrics 2007; 119:273-280

21. Updated Levels of Neonatal Care
• Basis to compare health outcomes, resource
use, and health care costs
• Standardized nomenclature for public health
• Uniform definitions for pediatricians and
other health care professionals providing
neonatal care (and parents!)
• A foundation for consistent standards of
service by institutions and other organizations
focused on improvement of perinatal care
AAP Committee on Fetus and Newborn 2012; Guidelines for Perinatal Care 7th edition, 2012

22. Guidelines for Perinatal Care 7th
Edition - 2012
Editors
Laura Riley (ACOG)
Ann Stark (AAP)
Associate Editors
Sarah Kirkpatrick (ACOG)
LuAnn Papile (AAP)

23. Level I Well Newborn Nursery
• Provide neonatal resuscitation at every
delivery
• Evaluate and provide postnatal care to stable
term newborn infants
• Stabilize and provide care for infants 35 to 37
weeks gestation who are physiologically stable
• Stabilize newborns who are ill or born before
35 weeks gestation until transfer to a higher
level of care
Guidelines for Perinatal Care, 7th edition, 2012

24. Level II Special Care Nursery
• Level I capabilities plus
• Provide care for infants born at 32 weeks gestation or later
and weigh 1500 g or more who have physiologic
immaturity or are moderately ill with problems expected
to resolve rapidly and are not anticipated to need
subspecialty services on an urgent basis
• Provide care for infants convalescing after intensive care
• Provide mechanical ventilation for brief duration (less than
24 hours) or continuous positive airway pressure or both
• Stabilize infants born before 32 weeks gestation and weigh
less than 1500 g until transfer to a neonatal intensive care
facility
Guidelines for Perinatal Care, 7th edition, 2012

25. Level III Neonatal Intensive Care Unit
• Level II capabilities plus
• Provide sustained life support
• Provide comprehensive care for infants born
before 32 weeks of gestation and weigh less than
1500 g and infants born at all gestational ages
and birth weights with critical illness
• Provide a full range of respiratory support that
may include conventional ventilation and/or high
frequency ventilation and inhaled nitric oxide
Guidelines for Perinatal Care, 7th edition, 2012

26. Level III NICU - continued
• Provide prompt and readily available access to
a full range of pediatric medical subspecialists,
pediatric surgical specialists, pediatric
anesthesiologists, and pediatric
ophthalmologists
• Perform advanced imaging, with
interpretation on an urgent basis, including
computed tomography, magnetic resonance
imaging, and echocardiography
Guidelines for Perinatal Care, 7th edition, 2012

27. Level IV Regional NICU
• Level III capabilities plus
• Located within an institution with the capability
to provide surgical repair of complex congenital
or acquired conditions
• Maintain a full range of pediatric medical
subspecialists, pediatric surgical subspecialists,
and pediatric anesthesiologists at the site
• Facilitate transport and provide outreach
education
Guidelines for Perinatal Care, 7th edition, 2012

28. Level Health Care Provider types
I Pediatricians, family physicians, nurse
practitioners, other advanced practice nurses
II + Pediatric hospitalists, neonatologists, neonatal
nurse practitioners
III + Pediatric medical subspecialists*, pediatric
anesthesiologists*, pediatric surgeons, and
pediatric ophthalmologists*
*at the site or at a closely related institution by
prearranged consultative agreement
IV + Pediatric surgical subspecialists
Guidelines for Perinatal Care, 7th edition, 2012

29. Percent of VLBW Infants Delivered at
Hospital with Level III NICU
Source: MCHB, Title V Information System, 2009

30. Methods to Improve Provision of Risk
Appropriate and Evidence-Based Care
• Quality Improvement Methods
– Multidisciplinary
– Rapid cycle improvement
• State Collaboratives
– Reduce elective deliveries before 39 weeks
• Collaborative Improvement and Innovation
Network (COIIN)

31. COIIN Priority Strategies
• 13 states in southeastern US
– Quality improvement methods
• Infant mortality reduction strategies
– Perinatal regionalization
• 20% improvement from baseline in delivery of VLBW infants
in risk-appropriate locations by December 2013
– Prevent elective deliveries less than 39 weeks
– Prevention of Sudden Unexpected Infant Death
– Smoking cessation in pregnancy
– Interconception care

32. COIIN Strategy – First Steps
• Define hospital levels using new AAP criteria
– Caring for infants less than 35 weeks gestation?
– Providing > 24 hours of CPAP?
– Providing advanced respiratory therapy?
– Available pediatric subspecialists?
– Surgical care of complex conditions?
– Transport systems in place?
• Data
– Number of births and VLBW infants at each facility
– Calculate neonatal mortality rate by facility

33. Challenges
• Transport
– Geographical limitations (distance, weather)
– Maternal transport
– Back transport of convalescing baby
• Policy
– Limit number of NICUs in a region
• Financial
– NICU care is expensive

34. Summary
• Regionalization improves mortality because high-
risk infants are cared for at facilities that can
provide appropriate care
• Provides opportunities for clinical teams to
develop expertise
– Concentrates rare cases at a few sites
• Centralizes expensive technologies
• However, we need to learn more
– Optimal characteristics of a level III NICU such as
staffing (physicians, nurses, others); equipment
– Outcome measures other than mortality