Infant Development
Conditions
Brief summary
A 4 month growth monitoring study of healthy term infants fed iron fortified infant formula. Infants will be fed ad-libitum for 16 weeks and growth will be evaluated in terms of weight gain over the 16 weeks.
Detailed description
A Growth Monitoring Study conducted according to FDA established guidelines to evaluate the test infant formulas ability to promote normal growth and development.
Interventions
OTHERInfant Formula
Growth Monitoring Study of Infant Formula fed to Healthy Term Infants over a 16 week period
Sponsors
Validcare
Aussie Bubs, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Study infant formulas have been blinded
Intervention model description
Randomization and exclusive feeding of study formulas by 14 days of age. Breastfed Cohort will be evaluated over the 16 weeks.
Eligibility
Sex/Gender
ALL
Age
1 Days to 14 Days
Healthy volunteers
Yes
Inclusion criteria
* Healthy Term Infant
Exclusion criteria
* Any health condition that would negatively impact infant feeding and growth.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weight gain (g) from study entry to 16 weeks of study. | 16 weeks of Clinical Study | Growth Monitoring Study |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Recumbent length gain (cm) from study entry to 16 weeks of study. | 16 weeks of Clinical Study | Growth Monitoring Study |
| Head Circumference gain (cm) from study entry to 16 weeks of study | 16 weeks of Clinical Study | Growth Monitoring Study |
| Tolerance of study formulas over 16 weeks of study | 16 weeks of Clinical Study | Tolerance of the infant to the study formulas will be evaluated 5 times through the use of study diaries for 3 days before each study visit. |
Countries
United States
Outcome results
None listed