MedTrace Logo

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

NCT00625482 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL

Last updated 2021-04-23

No results posted yet for this study

Summary

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.

Conditions

  • Mortality
  • Morbidity
  • Growth
  • Neonatal Mortality

Interventions

BIOLOGICAL

OPV

BIOLOGICAL

OPV plus BCG

BIOLOGICAL

OPV

BIOLOGICAL

OPV plus BCG

Sponsors & Collaborators

  • March of Dimes

    collaborator OTHER

  • Danida

    collaborator UNKNOWN

  • Bandim Health Project

    lead OTHER

Study Design

Purpose
PREVENTION

Eligibility

Max Age
1 Month
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-02-29

Countries

  • Guinea-Bissau

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00625482 on ClinicalTrials.gov