An interventional study of Counseling and nutrition supplement in Lack of; Care, Infant (Child), Malnutrition, sponsored by Cornell University. Completed at 1 site in Haiti. Open to participants aged 6 Months to 18 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-09-15.
Sponsored by Cornell University · Not applicable, Interventional, and Prevention
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.
1,587 studies on the registry are indexed under Malnutrition; 237 are open to participants now.
This study's enrollment of 82 is close to the median of 90 across 1,134 interventional studies indexed under Malnutrition.
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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.
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
Time frame: end of intervention (approximately 12 months of age)
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
Time frame: Six-months post-intervention (approximately 18 months of age)
Change in prevalence of anemia during intervention
Prevalence of anemia (Hb \< 10.5 g/dl)
Time frame: end of intervention (approximately 12 months of age)
Dietary intake
dietary nutrient intakes assessed through 24-hour dietary recall
Time frame: end of intervention (approximately 12 months of age)
This study is completed, as verified in Sep 2011. You cannot join it, but the record below documents what was studied.
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Cornell University