A Study on the Effect of High-Calorie Infant Formula on Growth and Nutrition in HIV-Infected Infants

• Status: Completed
• Trial end date: 2005-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Collaborator: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Criteria

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.