Clinical Trial: Preventing Linear Growth Faltering Among Low Birth Weight Infants in Bangladesh

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Preventing Linear Growth Faltering and Reversal of Stunting Among Low Birth Weight Infants in Bangladesh: a Community-based Cluster Randomized Control Trial

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 Summary:

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)

Current Primary Outcome:

• Anthropometry - Recumbent Length [ Time Frame: Change from baseline in length over 12 months ]
  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.
• Anthropometry - Weight [ Time Frame: Change from baseline in weight over 12 months ]
  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.

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Infectious Morbidity [ Time Frame: Weekly for 52 weeks ]
  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.
• Infant and young child feeding [ Time Frame: Monthly for 12 months ]
  Information on age-specific feeding practices will be obtained monthly by trained nutritionists using standardized infant and young child feeding indicators.
• Blood collection and Hemoglobin (Hb) measurement [ Time Frame: 6 and 12 months post randomization ]
  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.).
• Socioeconomic status (SES) and demographic information [ Time Frame: Baseline ]
  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.
• Household Food Security [ Time Frame: Baseline ]
  Information on household food security will be collected using standardized questionnaires used in the same population.

Original Secondary Outcome: Same as current

Information By: The Hospital for Sick Children

Dates:
Date Received: October 16, 2011
Date Started: June 2010
Date Completion:
Last Updated: June 30, 2015
Last Verified: June 2015