Lufwanyama Neonatal Survival Project (LUNESP)

March 29, 2011 updated by: Boston University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

3559

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: intervention
TBAs who receive training and supplies for the intervention
Other: Neonatal resuscitation protocol
training in neonatal resuscitation and sepsis identification early treatment
Active Comparator: control
TBAs continuing with current standard of practice
Other: Standard of care
continued with current standard of care for birth attendants

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
mortality
Time Frame: day 28
day 28

Secondary Outcome Measures

Outcome Measure
Time Frame
perinatal mortality
Time Frame: day zero
day zero
sepsis mortality
Time Frame: deaths between days 1-28
deaths between days 1-28
cost effectiveness
Time Frame: days 0-28
days 0-28
successful delivery of nevirapine prophylaxis to HIV exposed deliveries
Time Frame: day zero umbilical cord dried blood spot
day zero umbilical cord dried blood spot

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston University

Collaborators

Tufts University

Investigators

  • Principal Investigator: Christopher J Gill, MD MS, Boston Universtiy
  • Study Director: Grace Mazala, RN, Lufwanyama District Health Management Team

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2006

Primary Completion (Actual)

September 1, 2008

Study Completion (Actual)

July 1, 2009

Study Registration Dates

First Submitted

August 20, 2007

First Submitted That Met QC Criteria

August 20, 2007

First Posted (Estimate)

August 21, 2007

Study Record Updates

Last Update Posted (Estimate)

March 31, 2011

Last Update Submitted That Met QC Criteria

March 29, 2011

Last Verified

March 1, 2011

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • GHS-A-00-03-00020-00-4

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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