Evaluation of an Infant Feeding Intervention for HIV-exposed Haitian Infants
Primary Purpose
Lack of; Care, Infant (Child), Malnutrition
Status
Completed
Phase
Not Applicable
Locations
Haiti
Study Type
Interventional
Intervention
Counseling and nutrition supplement
Sponsored by
About this trial
This is an interventional prevention trial for Lack of; Care, Infant (Child), Malnutrition focused on measuring infant feeding, HIV, growth, anemia
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
Sites / Locations
- GHESKIO Centres
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intervention participant
Arm Description
Outcomes
Primary Outcome Measures
Change in prevalence of growth faltering during the intervention
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
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
Prevalence of anemia (Hb < 10.5 g/dl)
Dietary intake
dietary nutrient intakes assessed through 24-hour dietary recall
Full Information
NCT ID
NCT01434238
First Posted
September 9, 2011
Last Updated
September 14, 2011
Sponsor
Cornell University
Collaborators
Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic, Weill Medical College of Cornell University, University of Virginia
1. Study Identification
Unique Protocol Identification Number
NCT01434238
Brief Title
Evaluation of an Infant Feeding Intervention for HIV-exposed Haitian Infants
Official Title
Evaluation of an Infant Feeding Support Strategy for HIV-exposed Infants 6-12 Months Old in Urban Haiti
Study Type
Interventional
2. Study Status
Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
May 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cornell University
Collaborators
Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic, Weill Medical College of Cornell University, University of Virginia
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lack of; Care, Infant (Child), Malnutrition
Keywords
infant feeding, HIV, growth, anemia
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
82 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention participant
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Counseling and nutrition supplement
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in prevalence of growth faltering during the intervention
Description
Change in weight-for-age, length-for-age and weight-for-length <-2 SD based on WHO 2006 Growth Standard
Time Frame
end of intervention (approximately 12 months of age)
Title
Change in prevalence of growth faltering post-intervention
Description
Change in weight-for-age, length-for-age and weight-for-length <-2 SD based on WHO 2006 Growth Standard
Time Frame
Six-months post-intervention (approximately 18 months of age)
Secondary Outcome Measure Information:
Title
Change in prevalence of anemia during intervention
Description
Prevalence of anemia (Hb < 10.5 g/dl)
Time Frame
end of intervention (approximately 12 months of age)
Title
Dietary intake
Description
dietary nutrient intakes assessed through 24-hour dietary recall
Time Frame
end of intervention (approximately 12 months of age)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
18 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rebecca Heidkamp, PhD
Organizational Affiliation
Cornell University
Official's Role
Principal Investigator
Facility Information:
Facility Name
GHESKIO Centres
City
Port-au-Prince
State/Province
Quest
Country
Haiti
12. IPD Sharing Statement
Citations:
PubMed Identifier
22378328
Citation
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.
Results Reference
derived
Learn more about this trial
Evaluation of an Infant Feeding Intervention for HIV-exposed Haitian Infants
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