Status:
COMPLETED
Preventing Linear Growth Faltering Among Low Birth Weight Infants in Bangladesh
Lead Sponsor:
The Hospital for Sick Children
Conditions:
Infant, Low Birth Weight
Eligibility:
All Genders
Phase:
PHASE3
Brief Summary
Low birth weight (LBW) infants are particularly vulnerable to frequent infections and consequent morbidity resulting in sub-optimal breastfeeding, limited ingestion of complementary foods and ultimate...
Detailed Description
General Objective To explore the relative effect of hand sanitizer and home fortification with an improved MNP (plus nutrition education) to prevent infections, improve feeding and ultimately to impro...
Eligibility Criteria
Inclusion
- infants born as singletons and full term (mothers will be identified at \~8 months or \>37 weeks gestation to avoid including premature babies who are at high risk of neonatal mortality).
- must have a birth weight ≥1800g and \<2500g.
- Families involved in the study must be planning to remain in the study community for the next 12 months
- written consent must be received from an authorized guardian.
- all pregnant women will be identified and visited during their 8th month of pregnancy. A local informant will be identified for birth notification, who will inform the CHW (with a cell phone) when a child is born. All newborns will be screened and those who meet the inclusion criteria will be enrolled.
Exclusion
- newborns with severe illnesses or congenital abnormalities /severe malformations that affect feeding will be excluded from the study.
- infants whose mothers did not survive during childbirth will be excluded.
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
467 Patients enrolled
Trial Details
Trial ID
NCT01455636
Start Date
June 1 2010
End Date
April 1 2012
Last Update
July 2 2015
Active Locations (2)
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1
Research and Evaluation Division, BRAC
Dhaka, Bangladesh
2
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G1X8