Growth and Tolerance of Infants Fed Infant Formulas

Completed · Not applicable

Conditions studied: Growth and Tolerance

In brief

To evaluate growth and tolerance of healthy term infants fed experimental infant formulas, a commercial infant formula and human breast milk.

Key facts

Study ID

NCT01808105

Run by

Abbott Nutrition

People needed

424

Starts

2013-04-01

Expected to finish

2014-02-01

Last updated by the study team

2014-06-02

Who can join

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

You may qualify if…

• Singleton from full term birth with a gestational age 37-42 weeks
• Birth weight > 2490 g (\~5 lbs 8 oz)
• Between 0 and 5 days of age
• Smoke-free home (no smoking in the house dwelling), and mothers in the breast-fed group are prohibited from smoking during the study period
• Parent(s) of formula-fed infants have elected not to breastfeed and confirm that their infant has been exclusively formula-fed since birth and confirm their intention is to exclusively feed their infant study infant formula for the duration of the study,
• Parent(s) of human milk-fed infants have elected to breastfeed and confirm that their infant has been exclusively human milk-fed (not donor milk) since birth and confirm their intention is to continue to exclusively feed human milk with vitamin/mineral supplementation for the duration of the study
• No administration vitamin or mineral supplements (excluding vitamin or mineral supplements containing vitamin D, if recommended by a healthcare professional), solid foods or juices to infants from enrollment through the duration of the study, unless instructed otherwise by their healthcare professional

You may not qualify if…

• Adverse maternal, fetal or infant medical history that has potential effects on tolerance, growth, and/or development
• Infants using medications, home remedies, herbal preparations, probiotics or rehydration fluids that might affect gastrointestinal (GI) tolerance may not be enrolled
• Treatment with antibiotics
• Mother intends to use a combination of breast and formula feeding

Where it is running

• Alabama Clinical Therapeutics, LLC — Birmingham, Alabama, United States
• Alabama Clinical Therapeutics — Dothan, Alabama, United States
• W.O.M.B Watching Over Mothers and Babies — Tucson, Arizona, United States
• Clinical Research Advantage/Colorado Springs Health Partners — Colorado Springs, Colorado, United States
• Norwich Pediatric Group, PC — Norwich, Connecticut, United States
• Atlantic Clinical Research Collaborative — Boynton Beach, Florida, United States
• Lake Mary Pediatrics — Orange City, Florida, United States
• SCORE Physician Alliance, LLC — St. Petersburg, Florida, United States
• USF, College of Medicine, Dept of Pediatrics — Tampa, Florida, United States
• Southeast Regional Research Group (SERRG) — Columbus, Georgia, United States
• PediaResearch, LLC — Evansville, Indiana, United States
• Northpoint Pediatrics, LLC — Indianapolis, Indiana, United States
• Lafayette Clinical Research — Lafayette, Indiana, United States
• Women's Clinic of Lincoln, PC — Lincoln, Nebraska, United States
• MetroHealth Medical Center — Cleveland, Ohio, United States
• Dayton Clinical Research — Dayton, Ohio, United States
• Ohio Pediatric Research Association, Inc — Dayton, Ohio, United States
• Institute of Clinical Research — Mayfield Heights, Ohio, United States
• Clinical Trials of America — Eugene, Oregon, United States
• Red Lion Pediatrics — Philadelphia, Pennsylvania, United States
• Sanford Research — Sioux Falls, South Dakota, United States
• Tanner Memorial Clinic — Layton, Utah, United States
• Rockwood Clinic, PS — Spokane, Washington, United States
• Clinical Research Puerto Rico — Guayama, Puerto Rico
• Ponce School of Medicine/ CAIMED Center — Ponce, Puerto Rico

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.