Evaluation of an Infant Feeding Intervention for HIV-exposed Haitian Infants

This study has been completed.
Sponsor:
Collaborators:
GHESKIO
Weill Medical College of Cornell University
University of Virginia
Information provided by (Responsible Party):
Cornell University
ClinicalTrials.gov Identifier:
NCT01434238
First received: September 9, 2011
Last updated: September 14, 2011
Last verified: September 2011
  Purpose

The purpose of this quasi-experimental study is to evaluate the effectiveness of an infant feeding intervention in improving growth and anemia outcomes among HIV-exposed infants 6-12 months of age.


Condition Intervention
Lack of; Care, Infant (Child), Malnutrition
Other: Counseling and nutrition supplement

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Evaluation of an Infant Feeding Support Strategy for HIV-exposed Infants 6-12 Months Old in Urban Haiti

Resource links provided by NLM:


Further study details as provided by Cornell University:

Primary Outcome Measures:
  • Change in prevalence of growth faltering during the intervention [ Time Frame: end of intervention (approximately 12 months of age) ] [ Designated as safety issue: No ]
    Change in weight-for-age, length-for-age and weight-for-length <-2 SD based on WHO 2006 Growth Standard

  • Change in prevalence of growth faltering post-intervention [ Time Frame: Six-months post-intervention (approximately 18 months of age) ] [ Designated as safety issue: No ]
    Change in weight-for-age, length-for-age and weight-for-length <-2 SD based on WHO 2006 Growth Standard


Secondary Outcome Measures:
  • Change in prevalence of anemia during intervention [ Time Frame: end of intervention (approximately 12 months of age) ] [ Designated as safety issue: No ]
    Prevalence of anemia (Hb < 10.5 g/dl)

  • Dietary intake [ Time Frame: end of intervention (approximately 12 months of age) ] [ Designated as safety issue: No ]
    dietary nutrient intakes assessed through 24-hour dietary recall


Enrollment: 82
Study Start Date: June 2008
Study Completion Date: May 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention participant Other: Counseling and nutrition supplement
24-week intervention that includes a) a daily ration of fortified lipid-based nutrient supplement and b) nutrition counseling delivered through biweekly group and individualized sessions. Dietary supplement is a locally- produced lipid-based nutrient spread (Meds and Foods for Kid, Cap Haitian, Haiti) that in a 65g daily ration provides 345 kcal energy and single allowance of key micronutrients for the 6-12 month age group.

Detailed Description:

The need for better nutrition during infancy to improve growth and child survival outcomes is well recognized and is especially acute in the context of maternal human immunodeficiency virus (HIV) infection. WHO Guidelines on Infant Feeding and HIV call for support of HIV-infected caregivers during infant feeding transitions across the first year of life. However, there are few published examples of programmatic approaches that effectively integrate PMTCT and infant feeding support at the service delivery level.

The objectives of this study are to develop and test an infant feeding support intervention among non-breastfed HIV-exposed infants age 6-12 months enrolled in the Prevention of Mother-to-Child Transmission of HIV program at the GHESKIO centres, an HIV and TB treatment clinic in urban Port-au-Prince, Haiti. The investigators hypothesize that growth and anemia outcomes will be better in the intervention cohort compared to historical controls. The investigators also hypothesize that the infant feeding support intervention will be feasible and acceptable to mothers and clinical staff.

To accomplish these objectives, the investigators will enroll 82 HIV-exposed infants age 5.5-6.5 months recruited from the GHESKIO pediatric clinic in a 24-week intervention that includes a) a daily ration of fortified lipid-based nutrient supplement and b) nutrition counseling delivered through biweekly group and individualized sessions. Data on growth, supplement use, infant feeding knowledge and practices will be collected every 4 weeks during the intervention period. Hemoglobin and dietary intake will be assessed at baseline, mid-point and end of intervention. Intervention children will be seen 6-months post intervention to assess growth and anemia outcomes. Growth and anemia outcomes in the intervention group will be compared to medical record data from same-age HIV-exposed children seen at GHESKIO in the previous year.

  Eligibility

Ages Eligible for Study:   6 Months to 18 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Confirmed maternal HIV-infection
  • Age 5.5-6.5 months at intervention start
  • Weight-for-length z-score > -3 SD (WHO 2006 reference)

Exclusion Criteria:

  • Confirmed or suspected allergy to peanuts
  • Participation in a concurrent clinical trial at GHESKIO
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01434238

Locations
Haiti
GHESKIO Centres
Port-au-Prince, Quest, Haiti
Sponsors and Collaborators
Cornell University
GHESKIO
Weill Medical College of Cornell University
University of Virginia
Investigators
Principal Investigator: Rebecca Heidkamp, PhD Cornell University
  More Information

No publications provided by Cornell University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Cornell University
ClinicalTrials.gov Identifier: NCT01434238     History of Changes
Other Study ID Numbers: IRB 0907000316
Study First Received: September 9, 2011
Last Updated: September 14, 2011
Health Authority: United States: Institutional Review Board
Haiti: Institutional Review Board

Keywords provided by Cornell University:
infant feeding
HIV
growth
anemia

Additional relevant MeSH terms:
Malnutrition
Nutrition Disorders

ClinicalTrials.gov processed this record on October 23, 2014