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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
March of Dimes
Danida
Information provided by:
Bandim Health Project
ClinicalTrials.gov Identifier:
NCT00625482
First received: February 18, 2008
Last updated: October 22, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention
Mortality
Morbidity
Growth
Neonatal Mortality
Biological: OPV
Biological: OPV plus BCG

Study Type: Interventional
Study Design: Primary Purpose: Prevention
Official Title: Sex-Differential Health Interventions In Low-Birth-Weight Infants

Resource links provided by NLM:


Further study details as provided by Bandim Health Project:

Primary Outcome Measures:
  • Mortality

Secondary Outcome Measures:
  • 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

Study Start Date: February 2008
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   up to 1 Month
Genders Eligible for Study:   Both
Criteria

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)
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00625482

Locations
Guinea-Bissau
Bandim Health Project
Bissau, Guinea-Bissau
Sponsors and Collaborators
Bandim Health Project
March of Dimes
Danida
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00625482     History of Changes
Other Study ID Numbers: 2007-7041-121
Study First Received: February 18, 2008
Last Updated: October 22, 2013
Health Authority: Denmark: Ethics Committee

Keywords provided by Bandim Health Project:
BCG vaccine
Oral polio vaccine
Vitamin A supplementation
Low-birth-weigth
Sex-differential
Prevention
Immunological parameters

Additional relevant MeSH terms:
Birth Weight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on August 19, 2014