Sex-Differential Health Interventions In Low-Birth-Weight Infants

April 22, 2021 updated by: Bandim Health Project

Our group has consistently found that the major interventions to reduce morbidity and mortality in low-income countries have sex-differential effects. These interventions include BCG vaccine, oral polio vaccination (OPV), and vitamin A supplementation (VAS).

Low-birth-weight (LBW) children constitute the largest high-risk group in low-income countries. According to current policy, they receive OPV at birth. Current evidence suggests that a policy of providing BCG with OPV for girls and VAS instead of OPV for boys at birth may improve survival in LBW neonates. This will be tested in a large randomized trial.

We experienced an unexpected cluster of deaths among boys in the VAS arm, which could be due to chance, but we decided to stop randomizing boys to OPV or VAS. Very recent evidence has suggested that low-birth-weight boys may benefit from BCG at birth as well. Hence, we have obtained ethical permission to continue the trial with randomization of boys to OPV or OPV plus BCG.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

No older than 1 year (Child)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Low-birth-weight infants (<2500 g)

Exclusion Criteria:

  • Already received BCG/OPV
  • Overtly sick or have malformations at the time of enrolment
  • Clinical signs of vitamin A deficiency (very unlikely)

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: Prevention

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Boys 1
OPV as usual
Biological: OPV
Experimental: Boys 2
OPV plus BCG
Biological: OPV plus BCG
Active Comparator: Girls 1
OPV as usual
Biological: OPV
Experimental: Girls 2
OPV plus BCG
Biological: OPV plus BCG

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Mortality

Secondary Outcome Measures

Outcome Measure
Growth
Overall severe morbidity as measured by number of hospitalizations
Morbidity due to rotavirus and malaria
BCG scar formation and PPD delayed type hypersensitivity (DTH) response
Changes in cytokine profile

Collaborators and Investigators

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

Sponsor

Bandim Health Project

Collaborators

March of Dimes
Danida

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

February 1, 2008

Study Registration Dates

First Submitted

February 18, 2008

First Submitted That Met QC Criteria

February 27, 2008

First Posted (Estimate)

February 28, 2008

Study Record Updates

Last Update Posted (Actual)

April 23, 2021

Last Update Submitted That Met QC Criteria

April 22, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2007-7041-121

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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Conditions

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Locations

3
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