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Sponsors and Collaborators: |
Bandim Health Project March of Dimes Danida |
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Information provided by: | Bandim Health Project |
ClinicalTrials.gov Identifier: | NCT00625482 |
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 |
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Mortality Morbidity Growth |
Biological: OPV Biological: Vitamin A supplementation Biological: OPV plus BCG |
Study Type: | Interventional |
Study Design: | Prevention |
Official Title: | Sex-Differential Health Interventions In Low-Birth-Weight Infants |
Study Start Date: | February 2008 |
Arms | Assigned Interventions |
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Boys 1: Active Comparator
OPV as usual
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Biological: OPV |
Boys 2: Experimental
Vitamin A supplementation
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Biological: Vitamin A supplementation |
Girls 1: Active Comparator
OPV as usual
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Biological: OPV |
Girls 2: Experimental
OPV plus BCG
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Biological: OPV plus BCG |
Ages Eligible for Study: | up to 1 Month |
Genders Eligible for Study: | Both |
Inclusion Criteria:
Exclusion Criteria:
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 |
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 |
BCG vaccine Oral polio vaccine Vitamin A supplementation Low-birth-weigth |
Sex-differential Prevention Immunological parameters |
BCG Vaccine Body Weight Birth Weight Signs and Symptoms |
Retinol palmitate Poliomyelitis Vitamin A |
Growth Substances Vitamins Physiological Effects of Drugs Micronutrients Pharmacologic Actions |