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Lufwanyama Neonatal Survival Project

NCT ID: NCT00518856

Last Updated: 2011-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

3559 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2009-07-31

Brief Summary

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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

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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

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Mortality

Keywords

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birth asphyxia neonatal sepsis maternal to child transmission of HIV

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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intervention

TBAs who receive training and supplies for the intervention

Group Type EXPERIMENTAL

Neonatal resuscitation protocol

Intervention Type OTHER

training in neonatal resuscitation and sepsis identification early treatment

control

TBAs continuing with current standard of practice

Group Type ACTIVE_COMPARATOR

Standard of care

Intervention Type OTHER

continued with current standard of care for birth attendants

Interventions

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Neonatal resuscitation protocol

training in neonatal resuscitation and sepsis identification early treatment

Intervention Type OTHER

Standard of care

continued with current standard of care for birth attendants

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Tufts University

OTHER

Sponsor Role collaborator

Boston University

OTHER

Sponsor Role lead

Responsible Party

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Boston University School of Public Health

Principal Investigators

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Christopher J Gill, MD MS

Role: PRINCIPAL_INVESTIGATOR

Boston Universtiy

Grace Mazala, RN

Role: STUDY_DIRECTOR

Lufwanyama District Health Management Team

Countries

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Zambia

References

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Gill CJ, Guerina NG, Mulenga C, Knapp AB, Mazala G, Hamer DH. Training Zambian traditional birth attendants to reduce neonatal mortality in the Lufwanyama Neonatal Survival Project (LUNESP). Int J Gynaecol Obstet. 2012 Jul;118(1):77-82. doi: 10.1016/j.ijgo.2012.02.012. Epub 2012 Apr 27.

Reference Type DERIVED
PMID: 22542215 (View on PubMed)

Gill CJ, Phiri-Mazala G, Guerina NG, Kasimba J, Mulenga C, MacLeod WB, Waitolo N, Knapp AB, Mirochnick M, Mazimba A, Fox MP, Sabin L, Seidenberg P, Simon JL, Hamer DH. Effect of training traditional birth attendants on neonatal mortality (Lufwanyama Neonatal Survival Project): randomised controlled study. BMJ. 2011 Feb 3;342:d346. doi: 10.1136/bmj.d346.

Reference Type DERIVED
PMID: 21292711 (View on PubMed)

Other Identifiers

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GHS-A-00-03-00020-00-4

Identifier Type: -

Identifier Source: org_study_id