Mortality
Conditions
Keywords
birth asphyxia, neonatal sepsis, maternal to child transmission of HIV
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.
Interventions
OTHERNeonatal resuscitation protocol
training in neonatal resuscitation and sepsis identification early treatment
OTHERStandard of care
continued with current standard of care for birth attendants
Sponsors
Tufts University
Boston University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
* TBA trained in safe delivery; * willing to sign informed consent; willing to be randomized; willing to adhere to study procedures
Exclusion criteria
* TBA living outside of Lufwanyama district
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| mortality | day 28 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Outcome results
None listed