Preventing Linear Growth Faltering Among Low Birth Weight Infants in Bangladesh (NCT01455636) | Clinical Trial Compass
CompletedPhase 3
Preventing Linear Growth Faltering Among Low Birth Weight Infants in Bangladesh
Bangladesh, Canada467 participantsStarted 2010-06
Plain-language 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 ultimately micronutrient deficiencies that result in post-natal linear growth faltering. The objective of this study is to facilitate improved feeding practices through the early reduction of infections using the innovative tools of water-based hand sanitizer (beginning at birth) and an improved micronutrient powder (I-MNP) (beginning at 6 months of age). A community-based cluster randomized controlled trial will be carried out in Bangladesh using a 2x2 factorial design. LBW infants (n=480) will be recruited at birth and allocated to either HS or No HS from 0 to 6 months. From 6 to 12 months, half of the children in each group will be randomized to receive I-MNP. All groups will receive nutrition and hygiene education from birth to 12 months. Recumbent length is the primary outcome; morbidity, dietary intake and hemoglobin will be assessed as secondary outcomes. By working with BRAC, the largest implementation agency in Bangladesh, there is the opportunity to translate the results directly and quickly into child health programs in Bangladesh.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Anthropometry - Recumbent Length
Timeframe: Change from baseline in length over 12 months
2
Anthropometry - Weight
Timeframe: Change from baseline in weight over 12 months