Infant Development
Conditions
Brief summary
This is a randomized, controlled, double-blind, multicenter parallel study to evaluate the growth, tolerance and compliance of healthy infants fed infant formulas with extensively hydrolyzed casein protein.
Interventions
Feed Ad Libitum
Feed Ad Libitum
Sponsors
Abbott Nutrition
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
0 Days to 14 Days
Healthy volunteers
Yes
Inclusion criteria
* Participant is judged to be in good health * Participant is a singleton from a full-term birth with a gestational age of 37-42 weeks * Participant's birth weight was \> 2490 g (\ 5 lbs. 8 oz.) * 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 vitamins, minerals (with the exception of Vitamin D supplements), solid foods or juices to their infant from enrollment throughout the duration of the study * Participant's parent(s) has voluntarily signed and dated an Informed Consent Form (ICF), approved by an Independent Ethics Committee/Institutional Review Board (IEC/IRB) and provided Health Insurance Portability and Accountability Act (HIPAA) (or other applicable privacy regulation) authorization
Exclusion criteria
* An adverse maternal, fetal or participant medical history that is thought by the investigator to have potential for effects on tolerance, growth, and/or development. * Participant is taking and plans to continue taking medications, home remedies, prebiotics, probiotics, herbal preparations or rehydration fluids that might affect gastrointestinal (GI) tolerance * Participant participates in another study that has not been approved as a concomitant study by AN. * Participant has an allergy or intolerance to any ingredient in the study product * Participant has been treated with antibiotics within 1 week prior to enrollment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weight | Day of Age (DOA) 14 to 119 | Interval weight gain per day |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Head Circumference | Study Day (SD) 1 to DOA 119 | Interval HC gain per day |
| Length | Study Day (SD) 1 to DOA 119 | Interval length gain per day |
| Stool Characteristics | Study Day (SD) 1 to DOA 119 | Parent Completed Diary |
| Formula Intake | Study Day (SD) 1 to DOA 119 | Parent Completed Diary |
Other
| Measure | Time frame | Description |
|---|---|---|
| Formula Satisfaction Questionnaire | Exit or DOA 119 | Parent completed questionnaire; 13 questions of up to 5 categories scaled in the negative direction |
| Infant Behavior Questionnaire | Exit or DOA 119 | Parent completed questionnaire; 22 questions with 5 categories scaled in the negative direction |
| Infant Feeding and Stool Patterns Questionnaire | Exit or DOA 119 | Parent completed questionnaire; 16 questions with 5 categories scaled in the negative direction |
Countries
United States
Outcome results
None listed