Healthy Infants
Conditions
Brief summary
Effects on weight will be monitored in healthy infant subjects consuming assigned infant formulas.
Interventions
OTHERControl Study Formula
feed as lib
OTHERExperimental Study Formula
feed as lib
Sponsors
Abbott Nutrition
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 9 Days
Healthy volunteers
Yes
Inclusion criteria
* Singleton, healthy infant * Gestational age of 37 to 42 weeks * Birth weight of 2500 grams or greater * Age between birth and 9 days of age * Parents agree to not administer mineral or vitamin supplements during the study period * Parents agree to feed study formula exclusively for the duration of the study
Exclusion criteria
* Maternal, fetal or perinatal history which may have adverse effects on growth * Multiple birth
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weight | 14 days of age to 112 days of age | weight gain during the study period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anthropometric Measurements | 14 days of age to 112 days of age | length, head circumference, and length gain |
| GI Tolerance | At visits 14 and 28 | daily stool number, stool consistency, formula intake |
| Lab Measurement | At 112 day visit | serum albumin |
Countries
United States
Outcome results
None listed