Growth and Tolerance of Young Infants Fed Infant Formulas

Abbott Nutrition25 sites in 2 countries424 target enrollmentApril 2013

Overview

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

Registry

clinicaltrials.gov

Start Date

April 2013

End Date

February 2014

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Sponsor

Responsible Party

Sponsor

•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

•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

Weight

Time Frame: Study Day (SD) 14 - 119

Weight gain per day

Length(Study Day (SD) 1, 14, 28, 42, 84 and 119 visits)
Stool Characteristics(Study Day (SD) 1-28; 3 Day Records prior to SD 42, 84 and 119 visits)
Feeding Tolerance(Study Day (SD) 1-28; 3 Day Records prior to SD 42, 84 and 119 visits)
Head Circumference(Study Day (SD) 1, 14, 28, 42, 84 and 119 visits)