Status:
COMPLETED
A Study on the Effect of High-Calorie Infant Formula on Growth and Nutrition in HIV-Infected Infants
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
HIV Infections
Eligibility:
All Genders
1-17 years
Phase:
NA
Brief 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,...
Detailed Description
In order to meet the optimal nutritional needs of HIV-infected infants, it is critical that nutritional intervention begin early. Early nutritional intervention may help reduce the susceptibility to o...
Eligibility 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.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
September 1 2005
Estimated Enrollment :
2400 Patients enrolled
Trial Details
Trial ID
NCT00000873
End Date
September 1 2005
Last Update
October 7 2013
Active Locations (72)
Enter a location and click search to find clinical trials sorted by distance.
1
Univ of Alabama at Birmingham - Pediatric
Birmingham, Alabama, United States, 35233
2
Univ of South Alabama
Mobile, Alabama, United States, 36604
3
Phoenix Childrens Hosp
Phoenix, Arizona, United States, 85006
4
UCSD Med Ctr / Pediatrics / Clinical Sciences
La Jolla, California, United States, 920930672