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

September 9, 2011
September 14, 2011
June 2008
January 2010   (final data collection date for primary outcome measure)
  • 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
Same as current
Complete list of historical versions of study NCT01434238 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Evaluation of an Infant Feeding Intervention for HIV-exposed Haitian Infants
Evaluation of an Infant Feeding Support Strategy for HIV-exposed Infants 6-12 Months Old in Urban Haiti

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.

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.

Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Lack of; Care, Infant (Child), Malnutrition
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.
Experimental: Intervention participant
Intervention: Other: Counseling and nutrition supplement
Heidkamp RA, Stoltzfus RJ, Fitzgerald DW, Pape JW. Growth in late infancy among HIV-exposed children in urban Haiti is associated with participation in a clinic-based infant feeding support intervention. J Nutr. 2012 Apr;142(4):774-80. doi: 10.3945/jn.111.155275. Epub 2012 Feb 29.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
82
May 2010
January 2010   (final data collection date for primary outcome measure)

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
Both
6 Months to 18 Months
Yes
Contact information is only displayed when the study is recruiting subjects
Haiti
 
NCT01434238
IRB 0907000316
No
Cornell University
Cornell University
  • GHESKIO
  • Weill Medical College of Cornell University
  • University of Virginia
Principal Investigator: Rebecca Heidkamp, PhD Cornell University
Cornell University
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP