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Completed

NCT Number: NCT01434238

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

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.

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Key information

Conditions

Lack of; Care, Infant (Child), Malnutrition Anemia Hematologic Diseases Hemic and Lymphatic Diseases Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases

Age range

6 month–18 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

GHESKIO Centres

Port-au-Prince, Quest, Haiti

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Counseling and nutrition supplement

Other

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 outcomes

  1. 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

  2. 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

  1. Change in prevalence of anemia during intervention

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

    Prevalence of anemia (Hb < 10.5 g/dl)

  2. Dietary intake

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

    dietary nutrient intakes assessed through 24-hour dietary recall

Sponsors and collaborators

Lead sponsor

Cornell University

Other

Collaborators

  • Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic
  • University of Virginia
  • Weill Medical College of Cornell University

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Sep 14, 2011
Registry last updated
Sep 15, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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