Lufwanyama Neonatal Survival Project
- Conditions
- Mortality
- Interventions
- Other: Standard of careOther: Neonatal resuscitation protocol
- Registration Number
- NCT00518856
- Lead Sponsor
- Boston University
- Brief Summary
We seek to determine whether we can reduce day 28 mortality in Zambian newborns by training traditional birth attendants a modified version of the neonatal resuscitation protocol (NRP) and by improving their abiltiy to identify sepsis and initiate antibiotics in the field.
- Detailed Description
This is a cluster randomized trial of the impact of providing additional training and supplies to traditional birth attendants in a rural setting in Zambia. 120 TBAs are randomized into intervention/control. Intervention TBAs receive NRP training, supplies for neonatal resuscitation, receiving blankets for thermoregulation, and amoxicillin tablets. Control TBAs continue according to prior standard of care. Primary outcome is mortality at 28 days life as a proportion of births attended by TBAs in each study arm.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 3559
- TBA trained in safe delivery;
- willing to sign informed consent; willing to be randomized; willing to adhere to study procedures
- TBA living outside of Lufwanyama district
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description control Standard of care TBAs continuing with current standard of practice intervention Neonatal resuscitation protocol TBAs who receive training and supplies for the intervention
- Primary Outcome Measures
Name Time Method mortality day 28
- Secondary Outcome Measures
Name Time Method perinatal mortality day zero sepsis mortality deaths between days 1-28 cost effectiveness days 0-28 successful delivery of nevirapine prophylaxis to HIV exposed deliveries day zero umbilical cord dried blood spot