Healthy Term Infants
Conditions
Brief summary
The objective of this study is to evaluate the effect of two experimental milk-based infant formulas on the growth and gastrointestinal (GI) tolerance of term infants.
Interventions
OTHERMilk based infant formula powder
milk based infant formula ad lib
OTHERInvestigational Infant Formula #1
Milk based infant formula ad lib
OTHERInvestigational Infant Formula #2
Milk based infant formula powder ad lib
OTHERHuman Milk
Human milk ad 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
1 Days to 11 Days
Healthy volunteers
Yes
Inclusion criteria
* in good health * singleton full term birth * Birth weight \> 2490 g. * Infant is between 0 and 11 days of age * Infants using medications , home remedies , herbal preparations, prebiotics, probiotics or rehydration fluids that might affect GI tolerance * If formula-fed, parent(s) confirm their intention to feed their infant the study product as the sole source of nutrition for the duration of the study * If human milk-fed, parent(s) confirm their intention to feed their infant human milk as the sole source of nutrition * not consuming vitamin or mineral supplements, solid foods or juices through the duration of the study
Exclusion criteria
adverse maternal, fetal or infant medical history with potential for effects on tolerance, growth, and/or development.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| weight gain | 14 to 119 days of age |
Secondary
| Measure | Time frame |
|---|---|
| GI tolerance | 14 to 119 days of age |
| anthropometrics | 14 to 119 days of age |
Countries
United States
Outcome results
None listed