Growth and Tolerance of Young Infants Fed Infant Formulas

Completed · Phase 3

Conditions studied: Infant Newborn

In brief

This is a randomized, multi-center, double blind, parallel study to compare growth and tolerance of healthy term infants fed either control or experimental infant formula.

Key facts

Study ID

NCT01380886

Run by

Abbott Nutrition

People needed

209

Starts

2011-06-01

Expected to finish

2011-12-01

Last updated by the study team

2013-02-15

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• healthy infant
• full term
• birth weight > 2490 g
• 0 to 8 days of age
• parent/physician agree to not use medications affecting tolerance/growth
• parent agrees to sole source feeding of study formula
• parent agrees to not use vitamin/mineral supplements
• parent has signed consent/HIPAA authorization

You may not qualify if…

• any maternal, fetal, or infant history affecting growth and tolerance
• participation in any other study not preapproved by Abbott

Where it is running

• Norwich Pediatric Group, PC — Norwich, Connecticut, United States
• SCORE Physician Alliance, LLC — St. Petersburg, Florida, United States
• Northpoint Pedicatrics, LLC — Indianapolis, Indiana, United States
• Springs Medical Research, LLC — Owensboro, Kentucky, United States
• Clinical Research Center of Nevada — Las Vegas, Nevada, United States
• Cary Pediatric Center — Cary, North Carolina, United States
• MetroHealth Medical Center — Cleveland, Ohio, United States
• Ohio Pediatric Research Association, INC. — Huber Heights, Ohio, United States
• Institute of Clinical Research — Mayfield Heights, Ohio, United States
• The Cleveland Pediatric Research Center — Parma, Ohio, United States
• Sanford Clinic Family Medicine — Sioux Falls, South Dakota, United States
• DCOL Center for Clinical Research — Longview, Texas, United States

Full record on ClinicalTrials.gov

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