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

Mortality Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00625482
• Other study ID #: 2007-7041-121
• Status: Completed
• Phase: N/A
• Start date: February 2008

Study information

• Verified date: April 2021
• Source: Bandim Health Project
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Gender: All
• Age group: N/A to 1 Month

Eligibility

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)

Related Conditions & MeSH terms

• Birth Weight
• Growth
• Morbidity
• Mortality
• Neonatal Mortality

Intervention

Biological:
• OPV

• OPV plus BCG

• OPV

• OPV plus BCG

Locations

Country	Name	City	State
Guinea-Bissau	Bandim Health Project	Bissau

Sponsors (3)

Lead Sponsor	Collaborator
Bandim Health Project	Danida, March of Dimes

Country where clinical trial is conducted

Guinea-Bissau, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality
Secondary	Overall severe morbidity as measured by number of hospitalizations
Secondary	Morbidity due to rotavirus and malaria
Secondary	Growth
Secondary	BCG scar formation and PPD delayed type hypersensitivity (DTH) response
Secondary	Changes in cytokine profile