Sex-Differential Health Interventions In Low-Birth-Weight Infants
Information source: Bandim Health Project
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Mortality; Morbidity; Growth; Neonatal Mortality
Intervention: OPV (Biological); OPV plus BCG (Biological); OPV (Biological); OPV plus BCG (Biological)
Phase: N/A
Status: Recruiting
Sponsored by: Bandim Health Project
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.
Clinical Details
Official title: Sex-Differential Health Interventions In Low-Birth-Weight Infants
Study design: Primary Purpose: Prevention
Primary outcome: Mortality
Secondary outcome: Overall severe morbidity as measured by number of hospitalizationsMorbidity due to rotavirus and malaria Growth BCG scar formation and PPD delayed type hypersensitivity (DTH) response Changes in cytokine profile
Eligibility
Minimum age: N/A.
Maximum age: 1 Month.
Gender(s): 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)
Locations and Contacts
Bandim Health Project, Bissau, Guinea-Bissau; Recruiting
Peter Aaby, MSc, DMSc, Phone: +4532683162, Email: p.aaby@bandim.org
Christine Benn, MD, PhD, Phone: +4532688354, Email: cb@ssi.dk
Peter Aaby, Principal Investigator
Additional Information
Starting date: February 2008
Last updated: December 3, 2011
|
