Global Network for Womens and Childrens Health Research Resuscitation: How to Save One Million Lives Per Year Albert Manasyan, MD; Wally Carlo, MD and the FIRST BREATH Study Group For the Global Network for Womens and Childrens 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 Sepsis0.5 mil Other1.2 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 SettingInstitution-based (first level health clinics) Community-based Birth AttendantsFormally-trained midwives All birth attendants including MDs, RNs, MWs, TBAs OutcomesEarly neonatal mortality (7 days), stillbirths, perinatal mortality Timeline2004 – – 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:e , 2010.

First Breath: Clinic Study ResultsPre-ENCPost-ENCp value All cause 7-day mortality/ p<0.001 Perinatal mortality/ p=0.002 Mortality due to asphyxia/ p=0.02 Mortality due to infection/ p=0.02 Mortality < 1500/1000gr576407p=0.049 SB rate/ NS Carlo W et al. Pediatrics 126:e , 2010.

Delivery by Birth Attendant TBA 37% Physician 16% Nurse/Midwife 28% Family members 19% Carlo et al. N Engl J Med. 362:614-23, Birth Attendant Home 10% Home 56% Hospital 25% Clinic 9%

First Breath: Common Protocol 1. Population-based prospective study 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) Stillbirth RR (CI) Post-ENC Rate/1000 Pre-ENC Rate/1000 Results 0.99 (0.81, 1.22) All cause 7-day mortality 0.85 (0.70, 1.02) Perinatal mortality Carlo et al. N Engl J Med. 362:614-23, 2010.

Pre-Post ENC Perinatal Mortality Rates by Birth Attendant Perinatal Mortality * * Family/ Unattended Traditional Birth Attendant Nurse/Midwife Physician All Birth Attendants 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 = $ years Cost per DALY = $5.24

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