Overview

This trial is active, not recruiting.

Conditions mortality, morbidity, growth, neonatal mortality
Treatments opv, opv plus bcg
Sponsor Bandim Health Project
Collaborator March of Dimes
Start date February 2008
Trial identifier NCT00625482, 2007-7041-121

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Primary purpose prevention
Arm
(Active Comparator)
OPV as usual
opv
(Experimental)
OPV plus BCG
opv plus bcg
(Active Comparator)
OPV as usual
opv
(Experimental)
OPV plus BCG
opv plus bcg

Primary Outcomes

Measure
Mortality
time frame:

Secondary Outcomes

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

Eligibility Criteria

Male or female participants up to 1 month old.

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)

Additional Information

Official title Sex-Differential Health Interventions In Low-Birth-Weight Infants
Trial information was received from ClinicalTrials.gov and was last updated in October 2013.
Information provided to ClinicalTrials.gov by Bandim Health Project.