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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 467 (actual)
• Sponsor: The Hospital for Sick Children · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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)

Conditions

• Infant, Low Birth Weight

Interventions

Type	Name	Description
OTHER	Hand Sanitizer	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.
DIETARY_SUPPLEMENT	Improved Micronutrient Powder	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	No hand sanitizer	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
DIETARY_SUPPLEMENT	No Micronutrient Powder	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.

Timeline

• Start date: 2010-06-01
• Primary completion: 2011-04-01
• Completion: 2012-04-01
• First posted: 2011-10-20
• Last updated: 2015-07-02

Locations

2 sites across 2 countries: Bangladesh, Canada