Growth and Tolerance of Hypoallergenic Formulas
The Effects on Growth and Tolerance of Hypoallergenic Formulas Fed to Term Infants
1 other identifier
observational
511
1 country
24
Brief Summary
This clinical trial will evaluate two investigational hypoallergenic infant formulas with a differing protein content to determine if they provide normal growth and are well tolerated by term infants as compared to a marketed hypoallergenic formula.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2011
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 13, 2011
CompletedFirst Posted
Study publicly available on registry
May 16, 2011
CompletedStudy Start
First participant enrolled
July 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedAugust 29, 2013
August 1, 2013
1.4 years
May 13, 2011
August 28, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Body weight measured at each study visit
3.5 months
Secondary Outcomes (5)
Recall of infant formula intake at each study visit
3.5 months
Body Length and Head Circumference measured at each study visit
3.5 months
Recall of stool characteristics and tolerance at each study visit
3.5 months
Medically-confirmed adverse events collected throughout the study period
3.5 months
Parental Product Assessment Questionnaire completed at Study Visit 2
once
Study Arms (3)
Control
Marketed hypoallergenic infant formula containing a probiotic
Experimental 1
An investigational hypoallergenic infant formula with a different protein content, containing the same probiotic as the control
Experimental 2
An investigational hypoallergenic infant formula with a different protein content, without a probiotic
Interventions
Eligibility Criteria
Heatly, term infants
You may qualify if:
- Singleton, 12-16 days of age at randomization
- Term infant with birth weight of a minimum of 2500 grams
- Solely formula fed
- Signed Informed Consent and Protected Health Information
You may not qualify if:
- History of underlying metabolic or chronic disease or immunocompromised
- Feeding difficulties or formula intolerance
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (24)
Birmingham Pediatric Associates
Birmingham, Alabama, 35205, United States
Southeastern Pediatric Associates
Dothan, Alabama, 36305, United States
Pediatrics East - Alabama Clinical Therapeutics
Pinson, Alabama, 35126, United States
Central Arkansas Pediatric Clinic
Benton, Arkansas, 72019, United States
The Children's Clinic of Jonesboro
Jonesboro, Arkansas, 72401, United States
Arkansas Pediatric Clinic
Little Rock, Arkansas, 72205, United States
Norwich Pediatric Group, P.C.
Norwich, Connecticut, 06360, United States
Altamonte Pediatric Associates
Lake Mary, Florida, 32746, United States
Children's Medical Association
Plantation, Florida, 33324, United States
North Georgia Clinical Research Center/White's Pediatrics
Dalton, Georgia, 30721, United States
Deaconess Clinic
Newburgh, Indiana, 47630, United States
PTCU/Children and Youth Project
Louisville, Kentucky, 40202, United States
Owensboro Pediatrics
Owensboro, Kentucky, 42303, United States
Woburn Pediatric Associates
Woburn, Massachusetts, 01801, United States
Gretchen Swanson Center for Nutrition
Omaha, Nebraska, 68105, United States
Capital Pediatrics & Adolescent Center
Raleigh, North Carolina, 27609, United States
Innovis Health South University
Fargo, North Dakota, 58103, United States
Pediatric Associates of Mt. Carmel, Inc
Cincinnati, Ohio, 45245, United States
Pediatric Associates of Fairfield, Inc
Fairfield, Ohio, 45014, United States
Red Lion Pediatrics
Philadelphia, Pennsylvania, 19114, United States
Primary Physicians Research, Inc
Pittsburgh, Pennsylvania, 15241, United States
The Jackson Clinic - North Jackson
Jackson, Tennessee, 38305, United States
Holston Medical Group
Kingsport, Tennessee, 37660, United States
Austin Diagnostic Clinic
Austin, Texas, 78745, United States
Related Publications (1)
Adams CB, Johnston WH, Deulofeut H, Leader J, Rhodes R, Yeiser M, Harris CL, Wampler JL, Hill RJ, Cooper T. Growth and tolerance of healthy, term infants fed lower protein extensively hydrolyzed or amino acid-based formula: double-blind, randomized, controlled trial. BMC Pediatr. 2021 Jul 21;21(1):323. doi: 10.1186/s12887-021-02617-z.
PMID: 34289820DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Timothy Cooper, M.D.
Mead Johnson Nutrition
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 13, 2011
First Posted
May 16, 2011
Study Start
July 1, 2011
Primary Completion
December 1, 2012
Study Completion
December 1, 2012
Last Updated
August 29, 2013
Record last verified: 2013-08