A Study on the Effect of High-Calorie Infant Formula on Growth and Nutrition in HIV-Infected Infants (NCT00000873) | Clinical Trial Compass
CompletedNot Applicable
A Study on the Effect of High-Calorie Infant Formula on Growth and Nutrition in HIV-Infected Infants
United States2,400 participants
Plain-language summary
This study examines the effects of an infant formula containing increased calories, as compared to commercial formulas, when given during the first 6 months of life. It will examine effects on growth, disease progress, immune system, and quality of life of infected infants.
HIV disease in infants often leads to nutritional deficiencies. Providing increased nutrition early in their lives may help the quality of life of children who contract HIV from their mothers.
Who can participate
Age range1 Day – 17 Days
SexALL
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Inclusion Criteria
Children may be eligible for this study if they:
* Are 1 to 17 days old. (This study has been changed. Originally, infants 1 to 15 days old were eligible for this study.)
* Weigh 4 or more pounds.
* Were born to an HIV-positive mother.
* Have a caregiver willing to measure and keep records of infant's food intake.
Exclusion Criteria
Children will not be eligible for this study if they:
* Are breast-fed.
* Have certain disorders, including the inability to feed by mouth, or a life-threatening condition.
* Take medication which affects growth.
Trial details
NCT IDNCT00000873
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)