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Clinical Trials/NCT01434238
NCT01434238
Completed
N/A

Evaluation of an Infant Feeding Support Strategy for HIV-exposed Infants 6-12 Months Old in Urban Haiti

Cornell University1 site in 1 country82 target enrollmentJune 2008

Overview

Phase
N/A
Intervention
Not specified
Conditions
Lack of; Care, Infant (Child), Malnutrition
Sponsor
Cornell University
Enrollment
82
Locations
1
Primary Endpoint
Change in prevalence of growth faltering during the intervention
Status
Completed
Last Updated
14 years ago

Overview

Brief Summary

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.

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.

Registry
clinicaltrials.gov
Start Date
June 2008
End Date
May 2010
Last Updated
14 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility 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

Outcomes

Primary Outcomes

Change in prevalence of growth faltering during the intervention

Time Frame: end of intervention (approximately 12 months of age)

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)

Change in weight-for-age, length-for-age and weight-for-length \<-2 SD based on WHO 2006 Growth Standard

Secondary Outcomes

  • Change in prevalence of anemia during intervention(end of intervention (approximately 12 months of age))
  • Dietary intake(end of intervention (approximately 12 months of age))

Study Sites (1)

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