Preventing Linear Growth Faltering Among Low Birth Weight Infants in Bangladesh
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ClinicalTrials.gov Identifier: NCT01455636 |
Recruitment Status :
Completed
First Posted : October 20, 2011
Last Update Posted : July 2, 2015
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Tracking Information | ||||
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First Submitted Date ICMJE | October 16, 2011 | |||
First Posted Date ICMJE | October 20, 2011 | |||
Last Update Posted Date | July 2, 2015 | |||
Study Start Date ICMJE | June 2010 | |||
Actual Primary Completion Date | April 2011 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Preventing Linear Growth Faltering Among Low Birth Weight Infants in Bangladesh | |||
Official Title ICMJE | Preventing Linear Growth Faltering and Reversal of Stunting Among Low Birth Weight Infants in Bangladesh: a Community-based Cluster Randomized Control Trial | |||
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 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. | |||
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 improve growth among LBW infants in Bangladesh. Specific Objectives Although the applicants clearly understand that the primary purpose of the Alive and Thrive RFP is to improve infant feeding, we believe that by preventing infections, feeding will improve and growth will accelerate. Thus our primary objective is to determine the relative effect of intervention packages to improve feeding and thus prevent or reverse linear growth faltering and reduce rates of stunting among LBW infants (Ha: Combination of all three interventions will improve feeding and prevent or reverse linear growth faltering and reduce rates of stunting) Secondary objectives (i) Investigate the effect of intervention packages on rates of diarrhea and acute respiratory tract infection (ARI). (Ha: Combination of all three interventions will reduce on rates of diarrhea and acute respiratory tract infection) (ii) Explore the effect of the intervention packages on energy and nutrient intakes of infants and their feeding behaviors. (Ha: Combination of all three interventions will increase energy and nutrient intakes of infants and improve the feeding behaviors) (iii) Determine the impact of the improved MNP on iron status (hemoglobin level in blood) in a subgroup. (Ha: The group receiving the improved MNP will have increased hemoglobin level in blood and reduced rates of anemia) |
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Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Care Provider, Investigator) Primary Purpose: Prevention |
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Condition ICMJE | Infant, Low Birth Weight | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
467 | |||
Original Estimated Enrollment ICMJE |
400 | |||
Actual Study Completion Date ICMJE | April 2012 | |||
Actual Primary Completion Date | April 2011 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | Child, Adult, Older Adult | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Bangladesh, Canada | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01455636 | |||
Other Study ID Numbers ICMJE | 1000014576 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Stanley Zlotkin, The Hospital for Sick Children | |||
Study Sponsor ICMJE | The Hospital for Sick Children | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | The Hospital for Sick Children | |||
Verification Date | June 2015 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |