Clinical Trials Directory

Trials / Completed

CompletedNCT00518856

Lufwanyama Neonatal Survival Project

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
3,559 (actual)
Sponsor
Boston University · Academic / Other
Sex
All
Age
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERNeonatal resuscitation protocoltraining in neonatal resuscitation and sepsis identification early treatment
OTHERStandard of carecontinued with current standard of care for birth attendants

Timeline

Start date
2006-09-01
Primary completion
2008-09-01
Completion
2009-07-01
First posted
2007-08-21
Last updated
2011-03-31

Source: ClinicalTrials.gov record NCT00518856. Inclusion in this directory is not an endorsement.