Preventing Linear Growth Faltering Among Low Birth Weight Infants in Bangladesh

The Hospital for Sick Children

Status and phase: Completed; Phase 3

Conditions: Infant, Low Birth Weight

Treatments: Other: No hand sanitizer; Dietary Supplement: Improved Micronutrient Powder; Dietary Supplement: No Micronutrient Powder; Other: Hand Sanitizer

Study type: Interventional

Funder types: Other

Identifiers

NCT01455636

1000014576

Details and patient eligibility

About

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.

Full 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)

Enrollment: 467 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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467 participants in 4 patient groups, including a placebo group

Hand hygiene with Hand Sanitizer (HS)

Experimental group

Description:

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.

Treatment:

Other: Hand Sanitizer

Hand hygiene with no Hand Sanitizer

Experimental group

Description:

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.

Treatment:

Other: Hand Sanitizer

Dietary Supplement: Improved Micronutrient Powder

Micronutrient Powder

Experimental group

Description:

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.

Treatment:

Dietary Supplement: No Micronutrient Powder

Dietary Supplement: Improved Micronutrient Powder

Control

Placebo Comparator group

Description:

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.

Treatment:

Dietary Supplement: No Micronutrient Powder

Other: No hand sanitizer