Preventing Linear Growth Faltering Among Low Birth Weight Infants in Bangladesh

NCT01455636 | Completed Phase 3

• 1 other identifier: 1000014576
• Study Type: interventional
• Target: 467
• Locations: 2 countries
• Sites: 2

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.

Conditions

Infant, Low Birth Weight

Keywords

pediatric; micronutrient powder; hand hygiene; low birth weight; infant feeding; hand sanitizers

Outcome Measures

Primary Outcomes (2)

• Anthropometry - Recumbent Length

  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.

  Change from baseline in length over 12 months

• Anthropometry - Weight

  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.

  Change from baseline in weight over 12 months

Secondary Outcomes (5)

• Infectious Morbidity

  Weekly for 52 weeks

• Infant and young child feeding

  Monthly for 12 months

• Blood collection and Hemoglobin (Hb) measurement

  6 and 12 months post randomization

• Socioeconomic status (SES) and demographic information

  Baseline

• Household Food Security

  Baseline

Study Arms (4)

Hand hygiene with Hand Sanitizer (HS)

EXPERIMENTAL

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.

Other: Hand Sanitizer

Hand hygiene with no Hand Sanitizer

EXPERIMENTAL

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.

Other: Hand Sanitizer; Dietary Supplement: Improved Micronutrient Powder

Micronutrient Powder

EXPERIMENTAL

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.

Dietary Supplement: Improved Micronutrient Powder; Dietary Supplement: No Micronutrient Powder

Control

PLACEBO COMPARATOR

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.

Other: No hand sanitizer; Dietary Supplement: No Micronutrient Powder

Interventions

Hand Sanitizer OTHER

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.

Hand hygiene with Hand Sanitizer (HS); Hand hygiene with no Hand Sanitizer

Improved Micronutrient Powder DIETARY_SUPPLEMENT

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.

Also known as: MNP

Hand hygiene with no Hand Sanitizer; Micronutrient Powder

No hand sanitizer OTHER

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

Control

No Micronutrient Powder DIETARY_SUPPLEMENT

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.

Control; Micronutrient Powder

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (2)

Research and Evaluation Division, BRAC

Dhaka, Bangladesh

Location

The Hospital for Sick Children

Toronto, Ontario, M5G1X8, Canada

Location

Related Publications (2)

• 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.

  PMID: 27053383 DERIVED

• 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.

  PMID: 25143374 DERIVED

MeSH Terms

Interventions

Hand Sanitizers

Intervention Hierarchy (Ancestors)

Anti-Infective Agents, Local; Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Disinfectants; Specialty Uses of Chemicals

Study Officials

• Stanley Zlotkin, MD

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Global Child Health

Study Record Dates

• First Submitted: October 16, 2011
• First Posted: October 20, 2011
• Study Start: June 1, 2010
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2012
• Last Updated: July 2, 2015

Record last verified: 2015-06

Locations

CA (1); BA (1)