Can a Million Neonatal Lives Per Year Be Saved?

1. Can a Million Neonatal Lives Per Year Be Saved? Wally Carlo, MD and the FIRST BREATH Study Group For the Global Network for Women’s and Children’s Health Research THE UNIVERSITY OF ALABAMA AT BIRMINGHAM

2. Objectives • Learn the magnitude of the contribution on neonatal mortality and stillbirths in developing countries to mortality worldwide. • Understand the large potential for Essential Newborn Care training in first level facility and community births to reduce perinatal mortality.

3. Background: Essential Newborn Care • 98% of the 4 million neonatal deaths/year and 98% of the 3 million stillbirths occur in developing countries/year. • The recently developed WHO Essential Newborn Care (ENC) course sets minimum standards for training birth attendants in neonatal care including: • neonatal resuscitation • routine care • kangaroo mother care • small baby care • thermoregulation • ENC should be evaluated at first level hospitals and home births.

4. Infant Mortality (per 1000 live births)

5. Percent of Neonatal Deaths Due to Asphyxia >50 Percent (%) Country Multiple sources

6. Percent of Neonatal Deaths due to Asphyxia in Mexico (based on death certificates) Death (%) Data – Secretaria de Salud, Mexico

7. Proportion of Infant Deaths Due to Neonatal Mortality is Increasing Percent (%) Abernaz and Victora. J Perinat 22:S10-S11, 2002

8. Objective: Essential Newborn Care • To assess change in knowledge and skills following ENC training for skilled and unskilled providers. • To assess the impact of ENC training on perinatal mortality in first level hospitals. • To assess the impact of ENC trainingin community births

9. Design/Methods ENC Educational Study • ENC training/certification of all providers in 4 sites (Argentina, Zambia, India and Pakistan) • The trainees were categorized into: • Skilled: physicians, midwives, nurses • Unskilled: Traditional Birth Attendants

10. Results: Mean Knowledge Scores Pre and Post ENC Training

11. Results: Mean Performance Scores Pre and Post ENC Training

12. Comparison of Protocols

13. Essential Newborn Care and NRP Training: First Level Health Clinics Design: Pre-Post controlled study with active baseline data collection Setting: Level 1 healthy 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.

14. Essential Newborn Care and NRP Training: First Level Health Clinics 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 < 1500/1000 576 407 p=0.049 SB rate/1000 4.9 4.9 NS Carlo W et al. Pediatrics 126:e1064-71, 2010.

15. 7-Day Neonatal Mortality With GEE Model p<0.001 * p<0.003 * 7 day mortality/1000 Carlo W et al. Pediatrics 126:e1064-71, 2010.

16. But most of the perinatal mortality worldwide occurs in deliveries at home by various levels of birth attendants including traditional birth attendants.

18. Primary Hypothesis: Community Based Study Hypothesis: Essential Newborn Care (ENC) training decreases all-cause early (7 day) neonatal and perinatal mortality in infants >1500 grams born at the community level. Carlo et al. N Engl J Med. 362:614-23, 2010.

19. Methods: Community Based Study • Population-based prospective study • 96 communities in 6 countries (7 clinical sites) • 3676 birth attendants trained in data collection and clinical measures (fetal heart rate monitoring, Apgar scoring, Ballard, Ellis neurological exam) • Active baseline data collection • Training in ENC 6. Post-ENC data collection

20. Results: Population - Community Based Study Pre-ENC Post-ENC Total Countries 6 6 6 Clusters 96 96 96 Screened 23,251 35,766 59,017 Consented 23,127 (99.5%) 35,697 (99.8%) 58,824 (99.7%) Enrolled* 22,629 (97.8%) 35,037 (98.1%) 57,666 (98.0%) 7-day FU 22,514 (99.5%) 34,709 (99.1%) 57,223 (99.2%) *Enrolled infants had birth weight ≥ 1,500 grams Carlo et al. N Engl J Med. 362:614-23, 2010.

21. Results: Mortality - Community Based Study 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) Delivered by birth attendant 42.7 33.3 0.78 (0.63, 0.96) Carlo et al. N Engl J Med. 362:614-23, 2010.

22. Type of Birth Attendant Family members 19% Physician 16% TBA 37% Nurse/ midwife 28% *Includes all consented subjects Carlo et al. N Engl J Med. 362:614-23, 2010.

23. Pre-Post ENC Stillbirth Rates by Birth Attendant Family/ Unattended Traditional BirthAttendant Nurse/Midwife Physician All Birth Attendants Stillbirth/1,000 births * * * Carlo et al. N Engl J Med. 362:614-23, 2010.

24. Pre-Post ENC Perinatal Mortality Rates by Birth Attendant Family/ Unattended Traditional BirthAttendant Nurse/Midwife Physician All Birth Attendants PerinatalMortality * * Carlo et al. N Engl J Med. 362:614-23, 2010.

25. Post-ENC Mortality Rates by Birth Attendant Perinatal Mortality Rate (/1000 births) Family member TBA Nurse/ midwife Physician Carlo et al. N Engl J Med. 362:614-23, 2010.

26. Results: Location of Birth Birth Attendant Home 10% Home 56% Clinic 9% Hospital 25% Carlo et al. N Engl J Med. 362:614-23, 2010.

27. Objective To evaluate the cost-effectiveness of the WHO Essential Newborn Care package of neonatal care interventions from a study in first level delivery clinics in the two largest cities in Zambia

28. Method: Population Low risk urban population (almost exclusively term uncomplicated deliveries) 98% of low risk deliveries in the two cities Part of a study of 71,689 neonates

29. 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

30. Results: Initial Direct Cost of ENC Training and First Year

31. Results: Cost Effectiveness Cost per life saved = Cost Reduction in death Cost per life saved = $20,224 (11.5/1000-6.8/1000) x 20,534 neonates Cost per life saved = $20,224 97 Cost per life saved = $208

32. Results: DALY Cost per DALY = Cost per life saved Life expectancy Cost per DALY = $208 39.7 years Cost per DALY = $5.24

33. Results: Maintenance Costs of ENC Per Year • Equipment and supplies replacement $ 5,133.78 • Training material $ 1,338.25 • Shipping $ 599.42 • Personnel (two part-time nurses) $ 7,056.00 Total $14,127.45 Cost per DALY of $3.67 (assumes replacement of all equipment, supplies, and training materials) Cost per DALY as low as <$2.00 (for nurses costs only, assumes no replacement of equipment, supplies, or training materials)

34. Potential Reduction in Perinatal Mortality with ENC Moderate High Very High Mortality Mortality Mortality NMR 16-30 NMR 31-45 NMR>45 At birth 33 million 50 million 21 million Intrapartum SB/neo mort 10.6/1000 18.8/1000 23.2/1000 67% SB/ 50% neo 4.3/1000 11.1/1000 13.8/1000 Lives saved 142,000 555,000 290,000 = 987,000 Excludes 30 million births worldwide Other estimates 244,000 to over 1 million Lawn et al. Int J Gynaecol Obstet. 107:S123-40, 2009 Little et al. Pediatrics 2010, in press

35. Conclusions: Community Study • WHO ENC training of birth attendants in communities reduced perinatal mortality and stillbirths by ~7/1000. • This reduction in mortality occurred despite 37% of deliveries attended TBAs and 19% of deliveries attended by family members. • Mortality rates were decreased post-ENC in the TBAs and nurse midwives to levels comparable to that of physicians.

36. Disminución de 24.2% 3% anual Disminución de 13.9% 2.8% anual T a s a * * Tasa por cada 1000 recién nacidos vivos estimados CONAPO Tasa por cada 1000 recién nacidos vivos registrados INEGI Fuente: DGIS, INEGI/CONAPO * Estimados Mortalidad Neonatal México 1990 - 2003

37. Arranque Parejo en la Vida Red de servicios de apoyo social Red de servicios de salud

38. Expectativas 2005-2006 Continuidad al Proyecto de Capacitación en Reanimación Neonatal para Personal Comunitario

39. Thanks To the Global Network Investigators and Staff Shivaprasad S. Goudar MD, MHPE Jawaharlal Nehru Medical College Sailajanandan Parida, MD Sriramchandra Bhanja Medical College Imtiaz Jehan, FCPS, MSc Aga Khan University Antoinette Tshefu, MD Kinshasa School of Public Health Elwyn Chomba, MD University Teaching Hospital; CIDRZ Fernando Althabe, MD Hospital de Clínicas, Montevideo Ana Garces, MD, MPH San Carlos University - Guatemala City Richard J. Derman, MD, MPH Univ of Missouri at Kansas City School of Medicine Pinaki Panigrahi, MD, PhD University of Maryland School of Medicine Robert L. Goldenberg, MD Drexel University College of Medicine Carl Bose, MD University of North Carolina at Chapel Hill Pierre Buekens, MD, PhD Tulane School of Public Health and Tropical Medicine Nancy Krebs, MD University of Colorado Health Sciences Center Elizabeth M. McClure, MEd RTI International Hrishikesh Chakraborty, DrPH RTI International Hillary Harris, MS RTI International Linda L. Wright, MD National Institute of Child Health and Human Dev Waldemar A. Carlo, MD University of Alabama at Birmingham; CIDRZ FIRST BREATH Study Group

40. Thanks To the Mothers and Their Babies

41. Acknowledgement Support for this project comes through the ######## [grant or contract] 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.