Healthy Term Infants Clinical Trial
Official title:
Growth and Tolerance of Healthy Term Infants to a New Infant Formula
Verified date | November 2010 |
Source | Abbott Nutrition |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 399 |
Est. completion date | October 2010 |
Est. primary completion date | October 2010 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | N/A to 11 Days |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Cary Pediatric Center | Cary | North Carolina |
United States | Wayzata Children's Clinic Ridgeview Research | Chaska | Minnesota |
United States | Dayton Clinical Research | Dayton | Ohio |
United States | New England Center for Clinical Research, Inc | Fall River | Massachusetts |
United States | Ohio Pediatric Research Association, Inc | Huber Heights | Ohio |
United States | Northpoint Pediatrics | Indianapolis | Indiana |
United States | Clinical Research Center of Nevada | Las Vegas | Nevada |
United States | Midwest Children's Health Research Institute, LLC | Lincoln | Nebraska |
United States | Arkansas Children's Hospital Research | Little Rock | Arkansas |
United States | DCOL Center for Clinical Research | Longview | Texas |
United States | University of Louisville Department of Pediatrics | Louisville | Kentucky |
United States | Facey Medical Foundation | Mission Hills | California |
United States | Norwich Pediatric Group | Norwich | Connecticut |
United States | Parma Pediatrics | Parma | Ohio |
United States | All Women's Healthcare of West Broward, Inc | Plantation | Florida |
United States | Sanford Clinic Family Medicine 34th and Kiwanis | Sioux Falls | South Dakota |
United States | Rockwood Clinic North Pediatrics | Spokane | Washington |
United States | SCORE Physician Alliance LLC | St. Petersburg | Florida |
United States | USF College of Medicine, USF Health, Department of Pediatrics | Tampa | Florida |
United States | Comprehensive Pediatrics, Inc | Westlake | Ohio |
Lead Sponsor | Collaborator |
---|---|
Abbott Nutrition |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | weight gain | 14 to 119 days of age | No | |
Secondary | GI tolerance | 14 to 119 days of age | No | |
Secondary | anthropometrics | 14 to 119 days of age | No |
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