Growth of Infants Fed an Extensively Hydrolyzed Infant Formula
NCT ID: NCT01210391
Last Updated: 2014-06-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
282 participants
INTERVENTIONAL
2010-11-30
2013-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
TRIPLE
Study Groups
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New hydrolyzed infant formula
New, extensively hydrolyzed infant formula
Extensively hydrolyzed whey infant formula
New hydrolyzed infant formula.
Commercially available infant formula
Commercially available, extensively hydrolyzed infant formula.
Extensively hydrolyzed casein infant formula
Commercially available infant formula.
Interventions
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Extensively hydrolyzed whey infant formula
New hydrolyzed infant formula.
Extensively hydrolyzed casein infant formula
Commercially available infant formula.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Full-term (\>= 37 weeks gestation)
* Birth weight between \>= 2500 and \< =4500 g
* 14 ± 3 days of age on enrollment
* Infant's mother has elected not to breastfeed
* baby has been exclusively formula fed a minimum of 3 days prior to enrollment
* Study explained and written information provided with Parent/Caregiver
* Informed consent signed (parent/legal representative)
Exclusion Criteria
* Suspected or known allergy to cow's milk protein
* Significant pre-natal and/or post-natal disease
* Any readmission to hospital (except for hyperbilirubinemia) prior to enrollment
* Infant has received oral or IV antibiotic therapy in the 10 days prior to enrollment
* Infant receiving prescription medication (with exception of topical antibiotics and/or treatment for thrush) or frequent use of over the counter medications except vitamin and mineral supplements
* Infant has received probiotics in the seven days prior to enrollment
* Infant currently participating in another clinical study
* Infant's family who in the Investigator's assessment cannot be expected to comply with the protocol
11 Days
4 Months
ALL
Yes
Sponsors
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Société des Produits Nestlé (SPN)
INDUSTRY
Responsible Party
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Principal Investigators
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Ricardo Sorensen, MD
Role: PRINCIPAL_INVESTIGATOR
Louisiana State University Health Sciences Center in New Orleans
Locations
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Colorado Springs Health Partners
Colorado Springs, Colorado, United States
Pedia Research
Newburgh, Indiana, United States
Pedia Research
Owensboro, Kentucky, United States
ARK-LA-Tex Pediatric Research
Bossier City, Louisiana, United States
The Clinical Trials Center
New Orleans, Louisiana, United States
Clinical Research of Nevada
Las Vegas, Nevada, United States
Institute of Clinical Research
Mayfield Heights, Ohio, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Cyn3rgy Research
Gresham, Oregon, United States
Square-1 Clinical Research
Erie, Pennsylvania, United States
Alpha Clinical Research
Clarksville, Tennessee, United States
Jackson Clinic
Jackson, Tennessee, United States
Scott & White Wells Branch Clinic
Austin, Texas, United States
Scott & White Killeen Clinic
Killeen, Texas, United States
DCOL Center for Research
Longview, Texas, United States
Southwest Children's Research Associates
San Antonio, Texas, United States
Scott & White Temple
Temple, Texas, United States
Tanner Clinic
Layton, Utah, United States
Clinical Research Partners
Richmond, Virginia, United States
Wenatchee Valley Medical Center
Wenatchee, Washington, United States
Countries
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Other Identifiers
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09.43.PED
Identifier Type: -
Identifier Source: org_study_id
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