Clinical trial NCT02132663: The Effects on Growth and Tolerance of a Routine Infant Formula Fed to Term Infants
Official title: The Effects on Growth and Tolerance of a Routine Infant Formula Fed to Term Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Growth of Term Infants
Lead sponsor: Mead Johnson Nutrition
Sponsor class: INDUSTRY
First posted: 2014-05-07
Enrollment: 315
Sex: ALL
Minimum age (years): 10
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: This clinical trial will evaluate an investigational infant formula with an alternate source of DHA to determine if it provides normal growth and if it is well tolerated by term infants as compared to a marketed routine infant formula.


Eligibility criteria: Inclusion Criteria:

* Singleton, 10-14 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 measured at each study visit
timeFrame: 3.5 months
measure: Recall of stool consistency measured at each study visit
timeFrame: 3.5 months
measure: Medically-confirmed adverse events collected throughout the study period
timeFrame: 3.5 months
measure: Head circumference measured at each study visit
timeFrame: 3.5 months
measure: Recall of gastrointestinal tolerance measured at each study visit
timeFrame: 3.5 months
measure: Blood Collection
timeFrame: Once at 120 days of age
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Birmingham Pediatric Associates
state: Alabama
city: Birmingham
country: United States
facility: Greenvale Pediatrics - Hoover
state: Alabama
city: Dothan
country: United States
facility: Southeastern Pediatric Association
state: Alabama
city: Pinson
country: United States
facility: Pediatrics East - Alabama Clinical Therapeutics
state: Alabama
city: Fayetteville
country: United States
facility: Northwest Arkansas Pediatric Clinic
state: Arkansas
city: Jonesboro
country: United States
facility: The Children's Clinic of Jonesboro, P.A.
state: Arkansas
city: Norwich
country: United States
facility: Norwich Pediatric Group, PC
state: Connecticut
city: Altamonte Springs
country: United States
facility: Children's Research, LLC
state: Florida
city: Sarasota
country: United States
facility: Physician Care Clinical Research
state: Florida
city: Evansville
country: United States
facility: Deaconess Clinical Research
state: Indiana
city: Owensboro
country: United States
facility: Owensboro Pediatrics
state: Kentucky
city: Woburn
country: United States
facility: Woburn Pediatic Associates
state: Massachusetts
city: Cary
country: United States
facility: Cary Pediatric Center
state: North Carolina
city: Raleigh
country: United States
facility: Capital Pediatrics & Adolescent Center
state: North Carolina
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: Westlake
country: United States
facility: UHMP Comprehensive Pediatrics
state: Ohio
city: Charleston
country: United States
facility: Coastal Pediatric Research
state: South Carolina
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
city: Longview
country: United States
facility: DCOL Center for Clinical Research
state: Texas
Study officials:
affiliation: Mead Johnson and Company
name: Carol Lynn Berseth, M.D.
role: STUDY_DIRECTOR
References:
citation: Yeiser M, Harris CL, Kirchoff AL, Patterson AC, Wampler JL, Zissman EN, Berseth CL. Growth and tolerance of infants fed formula with a new algal source of docosahexaenoic acid: Double-blind, randomized, controlled trial. Prostaglandins Leukot Essent Fatty Acids. 2016 Dec;115:89-96. doi: 10.1016/j.plefa.2016.09.001. Epub 2016 Sep 29.