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

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ClinicalTrials.gov Identifier: NCT00625482
Recruitment Status : Unknown
Verified October 2013 by Bandim Health Project.
Recruitment status was:  Active, not recruiting
First Posted : February 28, 2008
Last Update Posted : October 23, 2013
Sponsor:
Collaborators:
March of Dimes
Danida
Information provided by:
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.


Condition or disease Intervention/treatment Phase
Mortality Morbidity Growth Neonatal Mortality Biological: OPV Biological: OPV plus BCG Not Applicable

Study Type : Interventional  (Clinical Trial)
Primary Purpose: Prevention
Official Title: Sex-Differential Health Interventions In Low-Birth-Weight Infants
Study Start Date : February 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Mortality

Secondary Outcome Measures :
  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


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Ages Eligible for Study:   up to 1 Month   (Child)
Sexes Eligible for Study:   All
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00625482


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00625482     History of Changes
Other Study ID Numbers: 2007-7041-121
First Posted: February 28, 2008    Key Record Dates
Last Update Posted: October 23, 2013
Last Verified: October 2013

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