Growth and Tolerance
Conditions
Brief summary
Effects on weight and weight gain will be monitored in healthy term infants fed assigned infant formulas.
Interventions
OTHERRTF Infant Formula
a RTF extensively hydrolyzed infant formula
OTHERPowder Infant Formula
a powdered extensively hydrolyzed infant formula.
Sponsors
Abbott Nutrition
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 9 Days
Healthy volunteers
Yes
Inclusion criteria
* Infants in good health. * Singleton, term birth with a gestational age of 37 to 42 weeks. * Birth weight of 2500 g (5 lb 8 oz) or greater. * Between 0 and 9 days of age at enrollment. * Not receiving vitamin or mineral supplements.
Exclusion criteria
\- Maternal, fetal or perinatal medical history with potential for adverse effects on growth or development.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Weight | Study day 1 to 112 days of age |
Secondary
| Measure | Time frame |
|---|---|
| Length | Study day 1 to 112 days of age |
| Head Circumference | Study day 1 to 112 days of age |
| Study Formula Intake | Enrollment to 112 days of age |
| Incidence of Spit Up | Enrollment to 112 days of age |
| Stool Pattern | Enrollment to 112 days of age |
Countries
United States
Outcome results
None listed