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

Not Applicable

Completed

• Conditions: Mortality; Neonatal Mortality; Morbidity; Growth
• Interventions: Biological: OPV; Biological: OPV plus BCG

• Registration Number: NCT00625482
• Lead Sponsor: Bandim Health Project

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02
• Study First Submitted: 2008-02-18
• Study First Submitted QC: 2008-02-27
• Study First Posted: 2008-02-28
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-22
• Last Update Posted: 2021-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Boys 1	OPV	OPV as usual
Girls 2	OPV plus BCG	OPV plus BCG
Boys 2	OPV plus BCG	OPV plus BCG
Girls 1	OPV	OPV as usual

Primary Outcome Measures

Name	Time	Method
Mortality

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Bandim Health Project; 🇬🇼 Bissau, Guinea-Bissau