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

Lack of; Care, Infant (Child), Malnutrition Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01434238
• Other study ID #: IRB 0907000316
• Status: Completed
• Phase: N/A
• First received: September 9, 2011
• Last updated: September 14, 2011
• Start date: June 2008
• Est. completion date: May 2010

Study information

• Verified date: September 2011
• Source: Cornell University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardHaiti: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: May 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Months to 18 Months

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Lack of; Care, Infant (Child), Malnutrition
• Malnutrition

Intervention

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.

Locations

Country	Name	City	State
Haiti	GHESKIO Centres	Port-au-Prince	Quest

Sponsors (4)

Lead Sponsor	Collaborator
Cornell University	Haitian Group for the Study for Kaposi’s Sarcome and Opportunistic Infections, University of Virginia, Weill Medical College of Cornell University

Country where clinical trial is conducted

Haiti, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	end of intervention (approximately 12 months of age)	No
Primary	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	Six-months post-intervention (approximately 18 months of age)	No
Secondary	Change in prevalence of anemia during intervention	Prevalence of anemia (Hb < 10.5 g/dl)	end of intervention (approximately 12 months of age)	No
Secondary	Dietary intake	dietary nutrient intakes assessed through 24-hour dietary recall	end of intervention (approximately 12 months of age)	No