Clinical trial NCT02860026: Growth and Tolerance of Healthy Term Infants Fed Cow's Milk-Based Infant Formulas
Official title: Growth and Tolerance of Healthy Term Infants Fed Cow's Milk-Based Infant Formulas
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Growth
Lead sponsor: Mead Johnson Nutrition
Sponsor class: INDUSTRY
First posted: 2016-08-09
Enrollment: 0
Sex: ALL
Minimum age (years): 10
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This clinical trial will compare the growth and tolerance of infants who consume an investigational cow's milk-based infant formula to those who consume a marketed cow's milk-based infant formula through approximately 4 months of age.


Eligibility criteria: Inclusion Criteria:

* Singleton 10-14 days of age at randomization
* Term infant with birth weight of minimum of 2500 grams
* Solely formula fed
* Signed informed consent and protected health information

Exclusion Criteria:

* History of underlying metabolic or chronic disease, anemia, or immune compromise
* Feeding difficulties or formula intolerance

Primary outcomes:
measure: Rate of body weight gain from 14 to 120 days of age
timeFrame: 3.5 months
Secondary outcomes:
measure: Recall of infant formula at each study visit
timeFrame: Up to 3.5 months
measure: Body length measured at each study visit
timeFrame: Up to 3.5 months
measure: Recall of stool characteristics questionnaire measured at each study visit
timeFrame: Up to 3.5 months
measure: Head circumference measured at each study visit
timeFrame: Up to 3.5 months
measure: Recall of gastrointestinal tolerance questionnaire at each study visit
timeFrame: Up to 3.5 months
measure: Medically confirmed adverse events collected throughout the study period
timeFrame: Up to 3.5 months
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: 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, P.C.
state: Connecticut
city: Lake Mary
country: United States
facility: Altamonte Pediatric Associates
state: Florida
city: Evansville
country: United States
facility: Deaconess Clinical Research
state: Indiana
city: Bardstown
country: United States
facility: Kentucky Pediatrics/Adult Research
state: Kentucky
city: Owensboro
country: United States
facility: Owensboro Pediatrics
state: Kentucky
city: Cincinnati
country: United States
facility: Pediatric Associates of Mt. Carmel, Inc.
state: Ohio
city: Dayton
country: United States
facility: Ohio Pediatric Research Association
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: Longview
country: United States
facility: DCOL Center for Clinical Research
state: Texas
Study officials:
affiliation: Mead Johnson Nutrition
name: Steven Wu
role: STUDY_DIRECTOR
References: