Clinical trial NCT01455636: Preventing Linear Growth Faltering Among Low Birth Weight Infants in Bangladesh
Official title: Preventing Linear Growth Faltering and Reversal of Stunting Among Low Birth Weight Infants in Bangladesh: a Community-based Cluster Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Infant, Low Birth Weight
Keywords: pediatric
micronutrient powder
hand hygiene
low birth weight
infant feeding
hand sanitizers
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2011-10-20
Enrollment: 467
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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)

Eligibility criteria: 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.

Primary outcomes:
measure: Anthropometry - Recumbent Length
timeFrame: Change from baseline in length over 12 months
measure: Anthropometry - Weight
timeFrame: Change from baseline in weight over 12 months
Secondary outcomes:
measure: Infectious Morbidity
timeFrame: Weekly for 52 weeks
measure: Infant and young child feeding
timeFrame: Monthly for 12 months
measure: Blood collection and Hemoglobin (Hb) measurement
timeFrame: 6 and 12 months post randomization
measure: Socioeconomic status (SES) and demographic information
timeFrame: Baseline
measure: Household Food Security
timeFrame: Baseline
Other outcomes:
Locations:
city: Dhaka
country: Bangladesh
facility: Research and Evaluation Division, BRAC
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children
name: Stanley Zlotkin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.