Clinical trial NCT01354366: Growth and Tolerance of Hypoallergenic Formulas
Official title: The Effects on Growth and Tolerance of Hypoallergenic Formulas Fed to Term Infants
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Growth of Term Infants
Lead sponsor: Mead Johnson Nutrition
Sponsor class: INDUSTRY
First posted: 2011-05-16
Enrollment: 511
Sex: ALL
Minimum age (years): 12
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Heatly, term infants

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* History of underlying metabolic or chronic disease or immunocompromised
* Feeding difficulties or formula intolerance

Primary outcomes:
measure: Body weight measured at each study visit
timeFrame: 3.5 months
Secondary outcomes:
measure: Recall of infant formula intake at each study visit
timeFrame: 3.5 months
measure: Body Length and Head Circumference measured at each study visit
timeFrame: 3.5 months
measure: Recall of stool characteristics and tolerance at each study visit
timeFrame: 3.5 months
measure: Medically-confirmed adverse events collected throughout the study period
timeFrame: 3.5 months
measure: Parental Product Assessment Questionnaire completed at Study Visit 2
timeFrame: once
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Birmingham Pediatric Associates
state: Alabama
city: Dothan
country: United States
facility: Southeastern Pediatric Associates
state: Alabama
city: Pinson
country: United States
facility: Pediatrics East - Alabama Clinical Therapeutics
state: Alabama
city: Benton
country: United States
facility: Central Arkansas Pediatric Clinic
state: Arkansas
city: Jonesboro
country: United States
facility: The Children's Clinic of Jonesboro
state: Arkansas
city: Little Rock
country: United States
facility: Arkansas Pediatric Clinic
state: Arkansas
city: Norwich
country: United States
facility: Norwich Pediatric Group, P.C.
state: Connecticut
city: Lake Mary
country: United States
facility: Altamonte Pediatric Associates
state: Florida
city: Plantation
country: United States
facility: Children's Medical Association
state: Florida
city: Dalton
country: United States
facility: North Georgia Clinical Research Center/White's Pediatrics
state: Georgia
city: Newburgh
country: United States
facility: Deaconess Clinic
state: Indiana
city: Louisville
country: United States
facility: PTCU/Children and Youth Project
state: Kentucky
city: Owensboro
country: United States
facility: Owensboro Pediatrics
state: Kentucky
city: Woburn
country: United States
facility: Woburn Pediatric Associates
state: Massachusetts
city: Omaha
country: United States
facility: Gretchen Swanson Center for Nutrition
state: Nebraska
city: Raleigh
country: United States
facility: Capital Pediatrics & Adolescent Center
state: North Carolina
city: Fargo
country: United States
facility: Innovis Health South University
state: North Dakota
city: Cincinnati
country: United States
facility: Pediatric Associates of Mt. Carmel, Inc
state: Ohio
city: Fairfield
country: United States
facility: Pediatric Associates of Fairfield, Inc
state: Ohio
city: Philadelphia
country: United States
facility: Red Lion Pediatrics
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Primary Physicians Research, Inc
state: Pennsylvania
city: Jackson
country: United States
facility: The Jackson Clinic - North Jackson
state: Tennessee
city: Kingsport
country: United States
facility: Holston Medical Group
state: Tennessee
city: Austin
country: United States
facility: Austin Diagnostic Clinic
state: Texas
Study officials:
affiliation: Mead Johnson Nutrition
name: Timothy Cooper, M.D.
role: STUDY_DIRECTOR
References:
citation: 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.