Preventing Linear Growth Faltering Among Low Birth Weight Infants in Bangladesh

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by The Hospital for Sick Children.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT01455636
First received: October 16, 2011
Last updated: October 19, 2011
Last verified: October 2011
  Purpose

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.


Condition Intervention Phase
Infant, Low Birth Weight
Other: Hand Sanitizer
Dietary Supplement: Improved Micronutrient Powder (I-MNP) and Nutritional Education
Other: Hand hygiene without hand sanitizer
Dietary Supplement: Placebo Micronutrient Powder and Nutritional Education
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: Preventing Linear Growth Faltering and Reversal of Stunting Among Low Birth Weight Infants in Bangladesh: a Community-based Cluster Randomized Control Trial

Resource links provided by NLM:


Further study details as provided by The Hospital for Sick Children:

Primary Outcome Measures:
  • Anthropometry - Recumbent Length [ Time Frame: Change from baseline in length over 12 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Infectious Morbidity [ Time Frame: Weekly for 52 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Information on household food security will be collected using standardized questionnaires used in the same population.


Estimated Enrollment: 400
Study Start Date: June 2010
Estimated Study Completion Date: April 2012
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Hand hygiene with water-based Hand Sanitizer (HS)

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
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.
Experimental: Hand hygiene with no Hand Sanitizer Group

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 hygiene without 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

Experimental: Improved Micronutrient Powder and Nutritional Education

From 6 months of age, children will be assigned to receive one sachet of Improved Micronutrient Powder, I-MNP (or placebo-MNP) per day for six months.

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 (I-MNP) and Nutritional Education
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 Name: MNP
Placebo Comparator: Placebo Micronutrient Powder and Nutritional Education

From 6 months of age, children will be assigned to receive one sachet of Improved Micronutrient Powder, I-MNP (or placebo-MNP) per day for six months.

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: Placebo Micronutrient Powder and Nutritional Education
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.

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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01455636

Locations
Bangladesh
Research and Evaluation Division, BRAC
Dhaka, Bangladesh
Canada, Ontario
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G1X8
Sponsors and Collaborators
The Hospital for Sick Children
Investigators
Principal Investigator: Stanley Zlotkin, MD The Hospital for Sick Children
  More Information

No publications provided

Responsible Party: The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT01455636     History of Changes
Other Study ID Numbers: 1000014576
Study First Received: October 16, 2011
Last Updated: October 19, 2011
Health Authority: Canada: Ethics Review Committee

Keywords provided by The Hospital for Sick Children:
pediatric
micronutrient powder
hand hygiene
low birth weight
infant feeding
hand sanitizers

Additional relevant MeSH terms:
Birth Weight
Body Weight
Signs and Symptoms
Micronutrients
Trace Elements
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014