Global Network for Women’s and Children’s Health Research

Resuscitation: How to Save One Million Lives Per Year

Albert Manasyan, MD; Wally Carlo, MD and the FIRST BREATH Study GroupFor the Global Network for Women’s and

Children’s Health Research

Stillbirth and Neonatal Deaths Per Year

• 98% of all stillbirths and neonatal deaths occur in developing countries

~ 2.6 million stillbirths ~ 3.5 million neonatal deaths

• Preterm 1.0 mil• Birth asphyxia 0.8 mil• Sepsis 0.5 mil• Other 1.2 mil

Background: Essential Newborn Care

• The WHO developed Essential Newborn Care (ENC) course sets minimum standards for training birth attendants in neonatal care including:• Basic resuscitation• Universal precautions• Routine neonatal care • Thermoregulation• Breastfeeding• Kangaroo mother (skin-to-skin) care• Care of the small baby• Danger signs

First Breath Protocols

The First Breath protocols were designed to address the impact of Essential Newborn Care (ENC) on perinatal mortality:

•First Breath: Clinic Study•First Breath: Common Protocol

Comparison of First Breath Protocols

First Breath:

Clinic Study

First Breath:

Common Protocol

Setting Institution-based

(first level health clinics)

Community-based

Birth Attendants Formally-trained midwives

All birth attendants including MDs, RNs, MWs, TBAs

Outcomes Early neonatal mortality (7 days), stillbirths, perinatal mortality

Early neonatal mortality (7 days), stillbirths, perinatal mortality

Timeline 2004 – 2006 2007 – 2008

First Breath: Clinic Study

Design: Pre-Post controlled study with active baseline data collection

Setting: Level 1 health delivery centers in Zambia

Interventions: WHO ENC (including resuscitation training) and NRP

Patients: 71,689 low risk newborns

Carlo W et al. Pediatrics 126:e1064-71, 2010.

First Breath: Clinic Study

Results Pre-ENC Post-ENC p value

All cause 7-day mortality/1000 11.5 6.8 p<0.001

Perinatal mortality/1000 18.3 12.9 p=0.002

Mortality due to asphyxia/1000 3.4 1.9 p=0.02

Mortality due to infection/1000 2.2 0.8 p=0.02

Mortality < 1500/1000gr 576 407 p=0.049

SB rate/1000 4.9 4.9 NS

Carlo W et al. Pediatrics 126:e1064-71, 2010.

Delivery by Birth Attendant

TBA37%

Physician16%

Nurse/Midwife 28%

Family members 19%

Carlo et al. N Engl J Med. 362:614-23, 2010.Carlo et al. N Engl J Med. 362:614-23, 2010.

Birth Attendant Home10%

Home 56% Hospital 25%

Clinic 9%

First Breath: Common Protocol

1. Population-based prospective study

2. 96 communities in 6 countries (7 clinical sites) in South America, Africa, and Asia

3. 3,676 birth attendants trained in data collection and clinical measures (fetal heart rate monitoring, Apgar scoring etc.)

4. Active baseline data collection

5. Training in ENC

6. Post-ENC data collection

First Breath: Common Protocol

0.69 (0.54 ,0.88)15.923.0Stillbirth

RR (CI)Post-ENCRate/1000

Pre-ENCRate/1000

Results

0.99 (0.81, 1.22)23.223.4All cause 7-day mortality

0.85 (0.70, 1.02)38.945.9Perinatal mortality

Carlo et al. N Engl J Med. 362:614-23, 2010.Carlo et al. N Engl J Med. 362:614-23, 2010.

Pre-Post ENC Perinatal Mortality Rates by Birth Attendant

Per

inat

al M

orta

lity

**

Family/ UnattendedTraditional Birth AttendantNurse/MidwifePhysicianAll Birth Attendants

Carlo et al. N Engl J Med. 362:614-23, 2010.Carlo et al. N Engl J Med. 362:614-23, 2010.

Methods: Cost Analysis

• Cost-effectiveness was calculated as follows:

Cost per life saved = Cost

Reduction in death

• Cost per disability-adjusted life years (DALY) was calculated as follows:

Cost per DALY = Cost per life saved

Life expectancy

Results: DALY

Cost per DALY = Cost per life saved

Life expectancy

Cost per DALY = $208

39.7 years

Cost per DALY = $5.24

Final Conclusions

1. WHO ENC training of midwives in first level centers reduced neonatal mortality by ~10/1000

2. This intervention was very cost-effective in first level facilities ($5 per DALY)

3. In communities, ENC reduced fresh stillbirths and perinatal mortality without increasing neonatal mortality

4. Survivors of birth asphyxia have low rates of impairment

Acknowledgement

Support for this project from the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), part of the National Institutes of Health within the U.S. Department of Health and Human Services, and the Bill and Melinda Gates Foundation