- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01455636
Preventing Linear Growth Faltering Among Low Birth Weight Infants in Bangladesh
Preventing Linear Growth Faltering and Reversal of Stunting Among Low Birth Weight Infants in Bangladesh: a Community-based Cluster Randomized Control Trial
Study Overview
Status
Conditions
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)
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Dhaka, Bangladesh
- Research and Evaluation Division, BRAC
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Ontario
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Toronto, Ontario, Canada, M5G1X8
- The Hospital for Sick Children
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Hand hygiene with Hand Sanitizer (HS)
To obtain 480 low birth weight infants the entire area of Kaliganj and Norsinghdi will be divided into 48 clusters based on the list of pregnant women identified through a household survey. 24 clusters will be randomized to receive Hand Sanitizer plus nutrition and hygiene education and the remaining 24 will receive only nutrition and hygiene education. |
The water-based hand sanitizer to be used in the current project will be produced in India by Hexagon Inc.
It will be dispensed via a foam dispenser, since it has been established that foam is preferable to gel because of the natural tendency to rub foam more thoroughly into one's hands.
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Experimental: Hand hygiene with no Hand Sanitizer
To obtain 480 low birth weight infants the entire area of Kaliganj and Norsinghdi will be divided into 48 clusters based on the list of pregnant women identified through a household survey. 24 clusters will be randomized to receive Hand Sanitizer plus nutrition and hygiene education and the remaining 24 will receive only nutrition and hygiene education. |
The water-based hand sanitizer to be used in the current project will be produced in India by Hexagon Inc.
It will be dispensed via a foam dispenser, since it has been established that foam is preferable to gel because of the natural tendency to rub foam more thoroughly into one's hands.
A modified and improved formulation of MNPs will be used.
The composition is specially designed to enhance appetite and growth with 17 essential micronutrients; including calcium and magnesium, as well as an increased amount of zinc (10 mg).
Previously MNP formulations (including the UNICEF formulation) contained only 5 mg of zinc and did not contain magnesium and calcium, which are essential nutrients for bone formation.
Other Names:
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Experimental: Micronutrient Powder
From 6 months of age, children in randomized clusters will be assigned to receive one sachet of Improved Micronutrient Powder, I-MNP per day for six months with or without hand sanitizer. Throughout the entire intervention period, mothers/caregivers of the children in all groups will receive simple, standardized, and age and culturally appropriate nutrition and health education that aims to improve feeding and health-seeking behavior and caring practices. |
A modified and improved formulation of MNPs will be used.
The composition is specially designed to enhance appetite and growth with 17 essential micronutrients; including calcium and magnesium, as well as an increased amount of zinc (10 mg).
Previously MNP formulations (including the UNICEF formulation) contained only 5 mg of zinc and did not contain magnesium and calcium, which are essential nutrients for bone formation.
Other Names:
I-MNP and placebo will be procured from a local pharmaceutical company in Dhaka, Bangladesh (Renata Pharma Ltd.).
The outer-packaging of the sachets of 'I-MNP' and 'placebo-MNP' will be identical except for a different numeric code for each.
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Placebo Comparator: Control
From 6 months of age, children in randomized clusters will be assigned to receive no hand sanitizer or no micronutrient powder Throughout the entire intervention period, mothers/caregivers of the children in all groups will receive simple, standardized, and age and culturally appropriate nutrition and health education that aims to improve feeding and health-seeking behavior and caring practices. |
I-MNP and placebo will be procured from a local pharmaceutical company in Dhaka, Bangladesh (Renata Pharma Ltd.).
The outer-packaging of the sachets of 'I-MNP' and 'placebo-MNP' will be identical except for a different numeric code for each.
All family members will receive hand-hygiene education with Information, Education and Communication (IEC) materials including pictorial messages describing critical points for hand-hygiene. No placebo for the hand sanitizers will be provided to families in Groups 3 and 4 because it would be unethical if families were to use an inactive hand-hygiene product as a substitute for routine hand-washing. Nevertheless, all groups will be instructed |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Anthropometry - Recumbent Length
Time Frame: Change from baseline in length over 12 months
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Recumbent length will be measured to 0.01cm on a locally constructed wooden stadiometer.
Anthropometric data will be converted to Z-scores using the WHO growth standards.
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Change from baseline in length over 12 months
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Anthropometry - Weight
Time Frame: Change from baseline in weight over 12 months
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weight using an infant balance with 15 g precision (SECA Model 345) calibrated on a regular, scheduled basis.
Anthropometric data will be converted to Z-scores using the WHO growth standards.
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Change from baseline in weight over 12 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Infectious Morbidity
Time Frame: Weekly for 52 weeks
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Diarrhea will be defined as >3 loose stools in a 24-h period or >1 loose stool containing blood.
Mothers are expected to use ORS and zinc tablets for all diarrhea episodes (provided free to study subjects irrespective of study group).
Acute Respiratory Infections (ARI) will be diagnosed according to World Health Organization Criteria Information on the occurrence, type and severity of diarrhea and ARI and health seeking be collected weekly.
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Weekly for 52 weeks
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Infant and young child feeding
Time Frame: Monthly for 12 months
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Information on age-specific feeding practices will be obtained monthly by trained nutritionists using standardized infant and young child feeding indicators.
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Monthly for 12 months
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Blood collection and Hemoglobin (Hb) measurement
Time Frame: 6 and 12 months post randomization
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A standardized finger-prick technique will be used to collect blood from the infants from a subsample of Groups 2 and 4 (at 6 and 12 months).
Hb will be measured using a portable Hemocue (Hemocue Inc.).
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6 and 12 months post randomization
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Socioeconomic status (SES) and demographic information
Time Frame: Baseline
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Household SES will be assessed by a pre-coded structured interview designed to obtain information on the household demographic structure, parental education, employment, material possessions and by inspection of housing quality.
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Baseline
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Household Food Security
Time Frame: Baseline
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Information on household food security will be collected using standardized questionnaires used in the same population.
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Baseline
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Stanley Zlotkin, MD, The Hospital for Sick Children
Publications and helpful links
General Publications
- Shafique S, Sellen DW, Lou W, Jalal CS, Jolly SP, Zlotkin SH. Mineral- and vitamin-enhanced micronutrient powder reduces stunting in full-term low-birth-weight infants receiving nutrition, health, and hygiene education: a 2 x 2 factorial, cluster-randomized trial in Bangladesh. Am J Clin Nutr. 2016 May;103(5):1357-69. doi: 10.3945/ajcn.115.117770. Epub 2016 Apr 6.
- Singla DR, Shafique S, Zlotkin SH, Aboud FE. A 22-element micronutrient powder benefits language but not cognition in Bangladeshi full-term low-birth-weight children. J Nutr. 2014 Nov;144(11):1803-10. doi: 10.3945/jn.114.193094. Epub 2014 Aug 20.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1000014576
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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