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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00625482
Enrollment
Unknown
Registered
2008-02-28
Start date
2008-02-29
Completion date
Unknown
Last updated
2021-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mortality, Morbidity, Growth, Neonatal Mortality

Keywords

BCG vaccine, Oral polio vaccine, Vitamin A supplementation, Low-birth-weigth, Sex-differential, Prevention, Immunological parameters

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.

Interventions

BIOLOGICALOPV
BIOLOGICALOPV plus BCG

Sponsors

March of Dimes
CollaboratorOTHER
Danida
CollaboratorUNKNOWN
Bandim Health Project
Lead SponsorOTHER

Study design

Primary purpose
PREVENTION

Eligibility

Sex/Gender
ALL
Age
No minimum to 1 Months

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)

Design outcomes

Primary

MeasureTime frame
Mortality

Secondary

MeasureTime frame
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

Countries

Guinea-Bissau

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 18, 2026