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OpenTrials
Completed

NCT Number: NCT00625482

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

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.

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Key information

Conditions

Mortality Growth Morbidity Neonatal Mortality

Age range

Up to 1 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bandim Health Project

Bissau, Guinea-Bissau

Who can participate

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

OPV

Biological

OPV plus BCG

Biological

Primary outcomes

  1. Mortality

Secondary outcomes

  1. Overall severe morbidity as measured by number of hospitalizations

  2. Morbidity due to rotavirus and malaria

  3. Growth

  4. BCG scar formation and PPD delayed type hypersensitivity (DTH) response

  5. Changes in cytokine profile

Sponsors and collaborators

Lead sponsor

Bandim Health Project

Other

Collaborators

  • Danida
  • March of Dimes

Registry information

Important dates

Study start
2008
First posted
Feb 28, 2008
Registry last updated
Apr 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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