Growth
Conditions
Brief summary
To compare growth and tolerance of healthy term infants fed two amino acid-based infant formulas.
Interventions
amino acid-based infant formula powder
amino acid-based infant formula powder
Sponsors
Abbott Nutrition
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
No minimum to 8 Days
Healthy volunteers
Yes
Inclusion criteria
* Subject is judged to be in good health. * Singleton from a full-term birth with a gestational age of 37 - 42 weeks. * Birth weight was ≥ 2490 g (\ 5 lbs. 8 oz.). * Subject is between 0 and 8 days of age at enrollment. * Parent(s) confirm their intention to feed their infant the study product as the sole source of nutrition for the duration of the study. * Parent(s) confirm their intention not to administer vitamin or mineral supplements (with the exception of Vitamin D-containing supplements), solid foods or juices to their infant from enrollment through the duration of the study. * Subject's parent(s) has voluntarily signed and dated an ICF prior to any participation in the study.
Exclusion criteria
* An adverse maternal, fetal or subject medical history that is thought by the investigator to have potential for effects on tolerance, growth, and/or development. * Subject is taking and plans to continue medications, home remedies, herbal preparations, prebiotics, probiotics or rehydration fluids that might affect gastrointestinal (GI) tolerance. * Subject participates in another study that has not been approved as a concomitant study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weight Gain | Study Day 14 to Study Day 119 | Infant scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| GI tolerance | Study Day 1 to Study Day 119 | Parent completed questionnaires |
| Length | Study Day 1 to Study Day 119 | Length board |
| Head Circumference | Study Day 1 to Study Day 119 | Measure tape |
| Weight | Study Day 1 to Study Day 119 | Infant scale |
Countries
United States
Outcome results
None listed