This presentation by Steve Wall of Save the Children, "Management of Serious Newborn Infections When Hospital Treatment is Not Possible" was part of a dynamic panel moderated by JSI's Dr. Penny Dawson on February 13, 2015 at the 14th World Congress on Public Health in Kolkata, India. Four speakers summarized evidence for interventions proven to reduce newborn mortality (e.g., chlorhexidine) and shared important policy and programmatic experiences in prevention and treatment of neonatal infections. JSI's Leela Khanal and Dr. Nosa Orobaton spoke about experiences from Nepal and Nigeria in scaling up chlorhexidine use in those countries. Another speaker shared results from the COMBINE trial in Ethiopia, implemented primarily by JSI with support from SAVE/SNL, which evaluated the impact on neonatal mortality of health extension worker-led management of bacterial infections.

1. M A N AG E M E N T O F S E R I O U S
N E W B O R N I N F E C T I O N S
W H E N H O S P I TA L
T R E AT M E N T I S N OT
P O S S I B L E
SteveWall, MD SM MSW FAAP
Saving Newborn Lives/Save the Children
WCPH, Kolkata
February 13, 2015

2. Questions to be addressed
 What is global evidence for community
management of serious newborn infections?
 What is additional impact of management of serious
newborn infections at primary level when referral is
not possible?
 Can serious newborn infections be treated by
simpler antibiotic regimens?

3. Figure 2
The Lancet 2015 385, 430-440DOI: (10.1016/S0140-6736(14)61698-6)
Copyright © 2015 Elsevier Ltd Terms and Conditions

4. CurrentWHO guidelines
 Hospitalization with 10 days of antibiotics
 Benzylpenicillin (or ampicillin) + gentamicin
 IMNCI – initial antibiotics (ampicillin + gentamicin)
at first level facility, with referral to hospital
 If referral not possible, outpatient treatment with
7-10 days of injectable antibiotics (ie, 3 injections
per day)

5. Hospital treatment is often not possible
 Lack of accessible hospitals with newborn care
services
 Hospitalization not acceptable to many/most
families
 Distance
 Cost
 Family hardship
 Perceived poor quality
 Socio-cultural factors

6. Current evidence:Home-based treatment
 Evidence from research studies - community-based
packages included home-based treatment of sepsis
 Bang (India): 62% NMR reduction
 Baqui (Bangladesh): 34% NMR reduction

7. ADDITIONAL IMPACT OF
TREATING SERIOUS NEWBORN
INFECTIONSAT PRIMARY LEVEL
Where referral is not possible

8. COMBINE Study (Ethiopia)
 Objective: To evaluate additional benefit on mortality of
management of newborn possible serious bacterial
infections (PSBI) by trained community health workers
 Ethiopia’s Health ExtensionWorkers (HEW),linked to
community health volunteers,provided management of PSBI
when referral was not possible
 HEWs trained to
 Identify signs or newborn PSBI and refer to health center
 Treat at health post if referral not possible or not accepted
 Gentamicin + amoxicillin for 7 days (7 total injections)

9. COMBINE Design
 Cluster RCT
 Comparison: MNH package via antenatal & postnatal home
visits by HEWs and volunteers, with referral of newborn
PSBI to facilities
 Intervention: Addition of HEW management of newborn
PSBI (7 days of gent + amox) if referral not accepted
 Outcome: Newborn mortality after day one

10. 0
20
40
60
80
100
120
Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2
2011 2012 2013
intervention HP Intervention HC Comparison HP Comparison HC
Trends in care seeking for newborn PSBI

11. Neonatal Mortality,Days 2-27
Risk ratio 0.70 (0.48,1.00)
Result. Neonatal deaths after day 1 of life in the
intervention arm were reduced 30% compared to the
comparison arm.
Control Intervention Total
Baseline 13.8 (120) 18.2 (184) 16.2 (304)
Endline 11.2 (100) 9.4 (90) 10.3 (190)

12. COMBINE Results
 Trained community health workers can improve
newborn survival by identifying and treating serious
newborn infections when referral is not possible
 Feasible to deliver this intervention effectively
through existing community health platforms
 Effective implementation of this intervention requires
programs to ensure supply,create demand,and
continuously monitor to assure coverage & quality

13. SIMPLER ANTIBIOTIC REGIMENS
FOR SERIOUS NEWBORN
INFECTIONS
In outpatient settings where referral
is not possible

14. SATT & AFRINEST
 SATT – Bangladesh
 SATT – Pakistan
 AFRINEST
 DRC
 Kenya
 Nigeria
 Common study protocol

15. SATT & AFRINEST Objective
 To evaluate if simpler antibiotic regimens are
equivalent to a ‘standard course’ of parenteral
antibiotics for treatment of possible serious
bacterial infections in young infants whose
families do not accept hospitalization.

16. Treatment regimens
Control arm (reference treatment)
 A : IM Gent and Procaine Pen once daily for 7 days
14 injections
Experimental arms
 B: IM Gent once daily and oralAmox twice daily for 7 days
7 injections
 C: IM Gent and Procaine Pen once daily for 2 days,thereafter
oral Amox twice daily for 5 days 4 injections
 D: IM Gent once daily and oral Amox twice daily for 2 days,
thereafter oral Amox twice daily for 5 days (ARINEST only)
2 injections

17. Inclusion and Exclusion Criteria
Inclusion Criteria:
 Fever (temp ≥380 C)
 Hypothermia (temp≤35.5 0 C)
 Lethargy (movement only with
stimulus)
 Severe chest indrawing
 Poor feeding
 Hospitalization not accepted
Exclusion Criteria:
 Signs of very severe infections
 Vomiting or unable to take
oral medication
 Weight <1500 grams

18. Results
 Simplified antibiotic regimens were equivalent to the
reference regimen with respect to ‘treatment failure’
rates
 Caveat: Evidence for simplest regimen (2 injections of
gent) is available from only one trial (AFRINEST)

19. Implications
 Infants with PSBI should be referred for hospital
treatment – and effective treatment ensured
 However, majority of families may not be able to
access hospital treatment at all or in time
 Where hospitalization is not possible, these infants can
be treated with simplified antibiotic regimens as
outpatients by trained health providers

20. Acknowledgements
 COMBINE
 InvestigatorTeam:Saving Newborn Lives/Save the Children Ethiopia, JSI, LSHTM,JHU,
UNICEF, Ethiopia Pediatric Society,
 Funding: BMGF
 SATT & AFRINEST
 Investigators:
 SATT Bangladesh:Projahnmo, JHU,AKU,
 AFRINEST PIs from DRC, Kenya,and Nigeria
 WHO
 LSHTM
 Funding: BMGF, USAID

21. Much progress,but much
to do . . .
- Thanks
Photo by Jason Tanner/Save the Children