Sex-Differential Health Interventions In Low-Birth-Weight Infants
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ClinicalTrials.gov Identifier: NCT00625482 |
Recruitment Status :
Completed
First Posted : February 28, 2008
Last Update Posted : April 23, 2021
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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 |
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 |
- Mortality
- 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
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Ages Eligible for Study: | up to 1 Month (Child) |
Sexes Eligible for Study: | All |
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)
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
Guinea-Bissau | |
Bandim Health Project | |
Bissau, Guinea-Bissau |
ClinicalTrials.gov Identifier: | NCT00625482 |
Other Study ID Numbers: |
2007-7041-121 |
First Posted: | February 28, 2008 Key Record Dates |
Last Update Posted: | April 23, 2021 |
Last Verified: | April 2021 |
BCG vaccine Oral polio vaccine Vitamin A supplementation Low-birth-weigth |
Sex-differential Prevention Immunological parameters |
Birth Weight Body Weight |