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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00518856
Other study ID # GHS-A-00-03-00020-00-4
Secondary ID
Status Completed
Phase N/A
First received August 20, 2007
Last updated March 29, 2011
Start date September 2006
Est. completion date July 2009

Study information

Verified date March 2011
Source Boston University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


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 information / eligibility

Status Completed
Enrollment 3559
Est. completion date July 2009
Est. primary completion date September 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
Neonatal resuscitation protocol
training in neonatal resuscitation and sepsis identification early treatment
Standard of care
continued with current standard of care for birth attendants

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Boston University Tufts University

Outcome

Type Measure Description Time frame Safety issue
Primary mortality day 28
Secondary perinatal mortality day zero
Secondary sepsis mortality deaths between days 1-28
Secondary cost effectiveness days 0-28
Secondary successful delivery of nevirapine prophylaxis to HIV exposed deliveries day zero umbilical cord dried blood spot
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