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
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
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
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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.
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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
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COMPONENTS OF THE INTERVENTION
Neonatal resuscitation Program (NRP)
Antibiotics with facilitated referral (AFR)
Skills
Skills
 Prevention of hypothermia
 Identification of trigger conditions
 Clear airway
 Single dose oral amoxicillin
 Position airway
 Accompany mother/infant pair to
nearest health facility
 Proper stimulation when needed
 Rescue breathing when needed
 Equipment
 Two flannel blankets/delivery
 Rubber bulb syringe/delivery
 Laerdal mask
 Laminated reference card (front)
 Equipment, drugs and supplies
 Two 250 mg amoxicillin capsules
 Mixing cup/spoon
 Oral syringe
 Bottle with chlorinated water
 Laminated reference card (back)
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RESULTS: Primary Endpoint
Cumulative All-Cause Mortality By Day 28
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LUNESP RESULTS :
Timing of Deaths During First Month
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
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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
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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
ZIKOMO!
TWALUMBA!
LUITUMEZI!
TWATASHA!
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