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 Group For 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 Birth asphyxia Sepsis Other 1.0 mil 0.8 mil 0.5 mil 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 Setting First Breath: Common Protocol Institution-based Community-based (first level health clinics) Birth Attendants Formally-trained midwives All birth attendants including MDs, RNs, MWs, TBAs Outcomes Early neonatal mortality Early neonatal mortality (7 days), stillbirths, (7 days), stillbirths, perinatal mortality 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 Family members 19% Birth Attendant Home 10% Physician 16% Clinic 9% TBA 37% Home 56% Nurse/Midwife 28% Carlo et al. N Engl J Med. 362:614-23, 2010. Hospital 25% 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 Results Pre-ENC Rate/1000 Post-ENC Rate/1000 RR (CI) Stillbirth 23.0 15.9 0.69 (0.54 ,0.88) All cause 7-day mortality 23.4 23.2 0.99 (0.81, 1.22) Perinatal mortality 45.9 38.9 0.85 (0.70, 1.02) Carlo et al. N Engl J Med. 362:614-23, 2010. Perinatal Mortality Pre-Post ENC Perinatal Mortality Rates by Birth Attendant 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 = Cost per DALY = $208 39.7 years $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