Clinical trial NCT01137877: Growth and Tolerance of Healthy Term Infants to a New Infant Formula
Official title: Growth and Tolerance of Healthy Term Infants to a New Infant Formula
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Healthy Term Infants
Lead sponsor: Abbott Nutrition
Sponsor class: INDUSTRY
First posted: 2010-06-07
Enrollment: 399
Sex: ALL
Minimum age (years): 1
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate the effect of two experimental milk-based infant formulas on the growth and gastrointestinal (GI) tolerance of term infants.


Eligibility criteria: Inclusion Criteria:

* in good health
* singleton full term birth
* Birth weight \> 2490 g.
* Infant is between 0 and 11 days of age
* Infants using medications , home remedies , herbal preparations, prebiotics, probiotics or rehydration fluids that might affect GI tolerance
* If formula-fed, parent(s) confirm their intention to feed their infant the study product as the sole source of nutrition for the duration of the study
* If human milk-fed, parent(s) confirm their intention to feed their infant human milk as the sole source of nutrition
* not consuming vitamin or mineral supplements, solid foods or juices through the duration of the study

Exclusion Criteria:

adverse maternal, fetal or infant medical history with potential for effects on tolerance, growth, and/or development.

Primary outcomes:
measure: weight gain
timeFrame: 14 to 119 days of age
Secondary outcomes:
measure: GI tolerance
timeFrame: 14 to 119 days of age
measure: anthropometrics
timeFrame: 14 to 119 days of age
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Arkansas Children's Hospital Research
state: Arkansas
city: Mission Hills
country: United States
facility: Facey Medical Foundation
state: California
city: Norwich
country: United States
facility: Norwich Pediatric Group
state: Connecticut
city: Plantation
country: United States
facility: All Women's Healthcare of West Broward, Inc
state: Florida
city: St. Petersburg
country: United States
facility: SCORE Physician Alliance LLC
state: Florida
city: Tampa
country: United States
facility: USF College of Medicine, USF Health, Department of Pediatrics
state: Florida
city: Indianapolis
country: United States
facility: Northpoint Pediatrics
state: Indiana
city: Louisville
country: United States
facility: University of Louisville Department of Pediatrics
state: Kentucky
city: Fall River
country: United States
facility: New England Center for Clinical Research, Inc
state: Massachusetts
city: Chaska
country: United States
facility: Wayzata Children's Clinic Ridgeview Research
state: Minnesota
city: Lincoln
country: United States
facility: Midwest Children's Health Research Institute, LLC
state: Nebraska
city: Las Vegas
country: United States
facility: Clinical Research Center of Nevada
state: Nevada
city: Cary
country: United States
facility: Cary Pediatric Center
state: North Carolina
city: Dayton
country: United States
facility: Dayton Clinical Research
state: Ohio
city: Huber Heights
country: United States
facility: Ohio Pediatric Research Association, Inc
state: Ohio
city: Parma
country: United States
facility: Parma Pediatrics
state: Ohio
city: Westlake
country: United States
facility: Comprehensive Pediatrics, Inc
state: Ohio
city: Sioux Falls
country: United States
facility: Sanford Clinic Family Medicine 34th and Kiwanis
state: South Dakota
city: Longview
country: United States
facility: DCOL Center for Clinical Research
state: Texas
city: Spokane
country: United States
facility: Rockwood Clinic North Pediatrics
state: Washington
Study officials:
affiliation: Abbott Nutrition
name: Timberly Williams, PhD
role: STUDY_CHAIR
References: