1. Maternal and Newborn Health Conference for Zambia’s Mothers and Babies Two Neonatal Survival Intervention Studies: Zambia Chlorhexidine Application Trial (ZamCAT) and Lufwanyama Neonatal Survival Project (LUNESP) Dr. Godfrey Biemba, MBChB, M.Sc Research Assistant Professor, Boston University Country Director, ZCAHRD

2. What is ZCAHRD? A registered non-governmental Applied and Implementation Research Organization Comprise Faculty and staff of the Center for Global Health and Development (CGHD) at Boston University (USA) Zambian public health professionals and specialists Project offices in Lusaka, Mazabuka, Choma, Kalomo, Livingstone. Central Office in Lusaka

3. Zambia Chlorhexidine Application Trial (ZamCAT) Cluster-randomized controlled effectiveness trial comparing: Daily cord cleansing with 4% chlorhexidine to Dry cord care (MoH guided standard practice) Primary outcome = neonatal mortality Target sample size = 42,500 mother/baby pairs Recruit pregnant women from 24 weeks gestation during ANC at facility or during outreach Total of 9 visits are made per participant post enrollment/consenting (4=prenatal & 5=postnatal). Six Districts of Southern Province (Choma, Monze, Mazabuka, Kalomo, Livingstone & Siavonga) with a total of 90 clusters 3

4. Zambia Chlorhexidine Application Trial (ZamCAT) Part of an Alliance for Maternal and Newborn Health Improvement (AMANHI) Multi-country study that aims to generate unique information to guide improvements on interventions to reduce maternal and newborn mortality and morbidity, and to prevent stillbirths Progress: >35,000 pregnant women enrolled; 28,000 deliveries; >25,000 completed study Under AMANHI, 270 female data collectors have been trained to (as part of maternal morbidity screening): Determine EDD using pregnancy wheels Measure urine protein using urine dipsticks Measure BP using portable microlife BP machines. 4

5. Lufwanyama Neonatal Survival Project  In communities with limited access to health care, is it possible to reduce neonatal mortality by training TBAs in skills that address some of the most important causes of neonatal mortality, notably birth asphyxia, neonatal hypothermia, and neonatal sepsis?  Cluster randomized, controlled effectiveness trial  Cluster= ‘All infants delivered by a given TBA’  Intervention: TBAs trained in NRP and antibiotics/facilitated referral (AFR) at baseline with refresher training every 3-4months  Control: TBAs providing existing standard of care  Primary endpoint: Mortality at 28 days of life among live-born infants  Additional endpoints:  Stillbirth rates, mortality rates at different times during 28 days  Cause of death analysis based on verbal autopsies Reviewed by 3 neonatologists, blinded to allocation group 5

6. 6 Neonatal resuscitation Program (NRP)  Skills  Prevention of hypothermia  Clear airway  Position airway  Proper stimulation when needed  Rescue breathing when needed  Equipment  Two flannel blankets/delivery  Rubber bulb syringe/delivery  Laerdal mask  Laminated reference card (front) Antibiotics with facilitated referral (AFR)  Skills  Identification of trigger conditions  Single dose oral amoxicillin  Accompany mother/infant pair to nearest health facility  Equipment, drugs and supplies  Two 250 mg amoxicillin capsules  Mixing cup/spoon  Oral syringe  Bottle with chlorinated water  Laminated reference card (back) COMPONENTS OF THE INTERVENTION

7. 7 RESULTS: Primary Endpoint Cumulative All-Cause Mortality By Day 28

8. 8 Death Rate on Day of Delivery: 19.9/1000 births (control) vs. 7.8/1000 births (intervention) RR = 0.4, 95% CI 0.19-0.83 LUNESP RESULTS : Timing of Deaths During First Month

9. LUNESP CONCLUSIONS Intervention was highly effective at reducing neonatal mortality 45% reduction in all-cause mortality by day 28 (Primary Endpoint) Decreased neonatal mortality rate by 18 per 1000 live births Note: Zambia national average: 34 deaths per 1000 live births 1 death averted per 56 deliveries attended by an intervention TBA Largest impact in earliest days of life Day of birth: 60% reduction Week one: 44% reduction Weeks 2-4: non-significant trend NRP appeared to be the most effective component of interventions Birth asphyxia deaths reduced by 70-80% No difference in sepsis deaths No difference in other causes of death 9

10. Acknowledgements Arthur Mazimba, David Hamer, Katherine Semrau and the rest of ZamCAT team Chris Gill, David Hamer, Kojo Yeboah-Anwti and the rest of LUNESP team Donors: BMGF, USAID 10 ZIKOMO! TWALUMBA! LUITUMEZI! TWATASHA!