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Sex-Differential Health Interventions In Low-Birth-Weight Infants
This study is currently recruiting participants.
Verified by Bandim Health Project, November 2008
Sponsors and Collaborators: Bandim Health Project
March of Dimes
Danida
Information provided by: Bandim Health Project
ClinicalTrials.gov Identifier: NCT00625482
  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.


Condition Intervention
Mortality
Morbidity
Growth
Biological: OPV
Biological: Vitamin A supplementation
Biological: OPV plus BCG

Drug Information available for: Vitamin A Retinol BCG Vaccine
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention
Official Title: Sex-Differential Health Interventions In Low-Birth-Weight Infants

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
Boys 1: Active Comparator
OPV as usual
Biological: OPV
Boys 2: Experimental
Vitamin A supplementation
Biological: Vitamin A supplementation
Girls 1: Active Comparator
OPV as usual
Biological: OPV
Girls 2: Experimental
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00625482

Locations
Guinea-Bissau
Bandim Health Project Recruiting
Bissau, Guinea-Bissau
Contact: Peter Aaby, MSc, DMSc     +4532683162     p.aaby@bandim.org    
Contact: Christine Benn, MD, PhD     +4532688354     cb@ssi.dk    
Principal Investigator: Peter Aaby            
Sponsors and Collaborators
Bandim Health Project
March of Dimes
Danida
  More Information

Study ID Numbers: 2007-7041-121
Study First Received: February 18, 2008
Last Updated: November 6, 2008
ClinicalTrials.gov Identifier: NCT00625482  
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

Study placed in the following topic categories:
BCG Vaccine
Body Weight
Birth Weight
Signs and Symptoms
Retinol palmitate
Poliomyelitis
Vitamin A

Additional relevant MeSH terms:
Growth Substances
Vitamins
Physiological Effects of Drugs
Micronutrients
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009