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
| Type | Name | Description |
|---|---|---|
| OTHER | Neonatal resuscitation protocol | training in neonatal resuscitation and sepsis identification early treatment |
| OTHER | Standard of care | continued 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.