Completed
A Randomized, Double-Blind, Controlled Study of an Increased Caloric Density Infant Formula and Its Effect on Growth and Nutritional Status in HIV-Infected Infants
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2013-10-07
2400
Participants Needed
72
Research Sites
N/A
Total Duration
On this page
Sponsors
N
National Institute of Allergy and Infectious Diseases (NIAID)
Lead Sponsor
E
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study on the Effect of High-Calorie Infant Formula on Growth and Nutrition in HIV-Infected Infants
Who Can Participate
Eligibility Criteria
You may qualify if you...
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.
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
Trial Site Locations
Total: 72 locations
1
Univ of Alabama at Birmingham - Pediatric
Birmingham, Alabama, United States, 35233
Status Unknown
2
Univ of South Alabama
Mobile, Alabama, United States, 36604
Status Unknown
3
Phoenix Childrens Hosp
Phoenix, Arizona, United States, 85006
Status Unknown
4
UCSD Med Ctr / Pediatrics / Clinical Sciences
La Jolla, California, United States, 920930672
Status Unknown
5
Long Beach Memorial (Pediatric)
Long Beach, California, United States, 90801
Status Unknown
6
Los Angeles County - USC Med Ctr
Los Angeles, California, United States, 90033
Status Unknown
7
Cedars Sinai / UCLA Med Ctr
Los Angeles, California, United States, 900481804
Status Unknown
8
UCLA Med Ctr / Pediatric
Los Angeles, California, United States, 900951752
Status Unknown
9
Harbor - UCLA Med Ctr / UCLA School of Medicine
Los Angeles, California, United States, 905022004
Status Unknown
10
Children's Hosp of Denver
Denver, Colorado, United States, 802181088
Status Unknown
11
Connecticut Children's Med Ctr
Farmington, Connecticut, United States, 060303805
Status Unknown
12
Yale Univ Med School
New Haven, Connecticut, United States, 06504
Status Unknown
13
Howard Univ Hosp
Washington D.C., District of Columbia, United States, 20060
Status Unknown
14
North Broward Hosp District
Fort Lauderdale, Florida, United States, 33311
Status Unknown
15
Univ of Florida Gainesville
Gainesville, Florida, United States, 32610
Status Unknown
16
Univ of Florida Health Science Ctr / Pediatrics
Jacksonville, Florida, United States, 32209
Status Unknown
17
Univ of Miami / Jackson Memorial Hosp
Miami, Florida, United States, 33136
Status Unknown
18
Univ of Miami (Pediatric)
Miami, Florida, United States, 33161
Status Unknown
19
Arnold Palmer Hosp for Children & Women
Orlando, Florida, United States, 32806
Status Unknown
20
Sacred Heart Children's Hosp / CMS of Florida
Pensacola, Florida, United States, 32503
Status Unknown
21
Palm Beach County Health Dept
Riviera Beach, Florida, United States, 33404
Status Unknown
22
Univ of South Florida
Tampa, Florida, United States, 33606
Status Unknown
23
Emory Univ Hosp / Pediatrics
Atlanta, Georgia, United States, 30306
Status Unknown
24
Med College of Georgia
Augusta, Georgia, United States, 30912
Status Unknown
25
The Med Ctr Inc
Columbus, Georgia, United States, 31901
Status Unknown
26
Univ of Illinois College of Medicine / Pediatrics
Chicago, Illinois, United States, 60612
Status Unknown
27
Chicago Children's Memorial Hosp
Chicago, Illinois, United States, 606143394
Status Unknown
28
Tulane Univ / Charity Hosp of New Orleans
New Orleans, Louisiana, United States, 701122699
Status Unknown
29
Univ of Maryland at Baltimore / Univ Med Ctr
Baltimore, Maryland, United States, 21201
Status Unknown
30
Johns Hopkins Hosp - Pediatric
Baltimore, Maryland, United States, 212874933
Status Unknown
31
Children's Hosp of Boston
Boston, Massachusetts, United States, 021155724
Status Unknown
32
Baystate Med Ctr of Springfield
Springfield, Massachusetts, United States, 01199
Status Unknown
33
Children's Hosp of Michigan
Detroit, Michigan, United States, 48201
Status Unknown
34
Univ of Mississippi Med Ctr
Jackson, Mississippi, United States, 39213
Status Unknown
35
Washington Univ School of Medicine
St Louis, Missouri, United States, 63110
Status Unknown
36
Cooper Hosp - Univ Med Ctr / UMDNJ - New Jersey Med Schl
Camden, New Jersey, United States, 08103
Status Unknown
37
UMDNJ - Robert Wood Johnson Med School / Pediatrics
New Brunswick, New Jersey, United States, 089030019
Status Unknown
38
St Peter's Med Ctr
New Brunswick, New Jersey, United States, 08903
Status Unknown
39
Univ of Medicine & Dentistry of New Jersey / Univ Hosp
Newark, New Jersey, United States, 071032714
Status Unknown
40
Saint Joseph's Hosp and Med Ctr/UMDNJ - New Jersey Med Schl
Newark, New Jersey, United States, 07103
Status Unknown
41
Children's Hosp at Albany Med Ctr
Albany, New York, United States, 12208
Status Unknown
42
SUNY - Brooklyn
Brooklyn, New York, United States, 11203
Status Unknown
43
North Shore Univ Hosp
Great Neck, New York, United States, 11021
Status Unknown
44
Bellevue Hosp / New York Univ Med Ctr
New York, New York, United States, 10016
Status Unknown
45
Cornell Univ Med College
New York, New York, United States, 10021
Status Unknown
46
Metropolitan Hosp Ctr
New York, New York, United States, 10029
Status Unknown
47
Columbia Presbyterian Med Ctr
New York, New York, United States, 10032
Status Unknown
48
Harlem Hosp Ctr
New York, New York, United States, 10037
Status Unknown
49
Univ of Rochester Med Ctr
Rochester, New York, United States, 146420001
Status Unknown
50
State Univ of New York at Stony Brook
Stony Brook, New York, United States, 117948111
Status Unknown
51
SUNY Health Sciences Ctr at Syracuse / Pediatrics
Syracuse, New York, United States, 13210
Status Unknown
52
Bronx Lebanon Hosp Ctr
The Bronx, New York, United States, 10457
Status Unknown
53
Duke Univ Med Ctr
Durham, North Carolina, United States, 277103499
Status Unknown
54
Univ of North Carolina at Chapel Hill / Duke Univ Med Ctr
Durham, North Carolina, United States, 27710
Status Unknown
55
Columbus Children's Hosp
Columbus, Ohio, United States, 432052696
Status Unknown
56
Med Univ of South Carolina
Charleston, South Carolina, United States, 294253312
Status Unknown
57
Univ of South Carolina School of Med
Columbia, South Carolina, United States, 29203
Status Unknown
58
Children's Med Ctr of Dallas
Dallas, Texas, United States, 75235
Status Unknown
59
Texas Children's Hosp / Baylor Univ
Houston, Texas, United States, 77030
Status Unknown
60
Univ of Texas Health Sciences Ctr
San Antonio, Texas, United States, 78284
Status Unknown
61
Med College of Virginia
Richmond, Virginia, United States, 23219
Status Unknown
62
Children's Hospital & Medical Center / Seattle ACTU
Seattle, Washington, United States, 981050371
Status Unknown
63
Federal University of Minas, Dept. of Pediatrics
Belo Horizonte-MG, Brazil
Status Unknown
64
Hosp dos Servidores do Estado
Rio de Janeiro, Brazil
Status Unknown
65
Hosp Univ Clementino Fraga Filho
Rio de Janeiro RJ, Brazil
Status Unknown
66
Ramon Ruiz Arnau Univ Hosp / Pediatrics
Bayamón, Puerto Rico, 00956
Status Unknown
67
Caguas Regional Hosp
Caguas, Puerto Rico, 00726
Status Unknown
68
Mayguez Med Ctr / Regional Immunology Clinic
Mayguez, Puerto Rico, 00680
Status Unknown
69
Ponce Univ Hosp
Ponce, Puerto Rico, 00731
Status Unknown
70
Univ of Puerto Rico / Univ Children's Hosp AIDS
San Juan, Puerto Rico, 009365067
Status Unknown
71
San Juan City Hosp
San Juan, Puerto Rico, 009367344
Status Unknown
72
Princess Margaret Hosp
Nassau, The Bahamas
Status Unknown
How is the study designed?
Study Type
INTERVENTIONAL
Masking
N/A
Allocation
N/A
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
0
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