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
225 participants
INTERVENTIONAL
2012-05-31
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
QUADRUPLE
Study Groups
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Amino Acid Formula
Hypoallergenic baby formula
Amino Acid Formula
Subjects will be fed the assigned study formula from enrollment to 4 months (112 days) of age.Infants will be fed orally, ad libitum with the assigned formula
Amino Acid commercial formula
Hypoallergenic commercial amino acid formula
Amino Acid formula
Subjects will be fed the assigned study formula from enrollment to 4 months (112 days) of age.Infants will be fed orally, ad libitum with the assigned formula
Interventions
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Amino Acid Formula
Subjects will be fed the assigned study formula from enrollment to 4 months (112 days) of age.Infants will be fed orally, ad libitum with the assigned formula
Amino Acid formula
Subjects will be fed the assigned study formula from enrollment to 4 months (112 days) of age.Infants will be fed orally, ad libitum with the assigned formula
Eligibility Criteria
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Inclusion Criteria
* Full-term (\>= 37 weeks gestation)
* Birth weight between \>= 2500 and \< =4500 g
* 0-17 days of age on enrolment (day 0 is day of birth)
* Infant's mother has elected not to breastfeed and to exclusively formula-feed infant
* Study explained and written information provided with Caregiver demonstrating understanding of the given information
* 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 enrolment
* 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 currently participating in another conflicting clinical study
* Infant's family who in the Investigator's assessment cannot be expected to comply with the protocol
17 Days
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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Marc Corkins, MD
Role: PRINCIPAL_INVESTIGATOR
Le Bonheur Children's Hospital
Locations
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Alabama Clinical Therapeutics
Birmingham, Alabama, United States
Alabama Clinical Therapeutics/Southlake Pediatrics
Birmingham, Alabama, United States
Clinical Research Consortium Arizona
Phoenix, Arizona, United States
Lutheran General Children's Hospital
Park Ridge, Illinois, United States
Nassim, MCMonigle, Mescia and Associates
New Albany, Indiana, United States
Bluegrass Clinical Research, Inc.
Louisville, Kentucky, United States
Southwestern Medical Clinic
Niles, Michigan, United States
Southwestern Medical Clinic
Stevensville, Michigan, United States
Women's Clinic of Lincoln, P.C.
Lincoln, Nebraska, United States
Blue Ridge Pediatric and Adolescent Medicine, Inc.
Boone, North Carolina, United States
Haywood Pediatric and Adolescent Medicine Group, P.A.
Clyde, North Carolina, United States
Tarheel Clinical Research
Raleigh, North Carolina, United States
Ohio Pediatric Research Assn.
Dayton, Ohio, United States
Institute of Clinical Research
Mayfield Heights, Ohio, United States
Spartanburg Medical Research
Spartanburg, South Carolina, United States
Jean Brown Research
Salt Lake City, Utah, United States
Clinical Research Specialists of Utah, Inc
Spanish Fork, Utah, United States
Countries
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References
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Amari S, Shahrook S, Namba F, Ota E, Mori R. Branched-chain amino acid supplementation for improving growth and development in term and preterm neonates. Cochrane Database Syst Rev. 2020 Oct 2;10(10):CD012273. doi: 10.1002/14651858.CD012273.pub2.
Other Identifiers
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09.56.PED
Identifier Type: -
Identifier Source: org_study_id
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