Growth and Tolerance
Conditions
Brief summary
This is a randomized, multicenter, controlled, double-blind, parallel study to evaluate growth and tolerance of healthy term infants fed milk-based infant formulas.
Interventions
Ready to feed infant formula, feed ad libitum
Ready to feed infant formula, 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
No minimum to 14 Days
Healthy volunteers
Yes
Inclusion criteria
* Participant is judged to be in good health as determined from participant's medical history. * 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) who elect to formula-feed the participant, confirm their intention to feed their infant the study product as the sole source of feeding during the study. * Parent(s) who elect to feed the participant human milk, confirm their intention to exclusively feed human milk as the sole source of feeding during the study. * Parent(s) of formula-fed infants confirm their intention not to administer vitamin or mineral supplements, (except for vitamin D supplements), solid foods or juices to their infant from enrollment through the duration of the study. * Parent(s) of human milk-fed infants confirm their intention not to administer solid foods or juices to their infant from enrollment through the duration of the study (vitamins and minerals are acceptable). * Participant's parent(s) has voluntarily signed and dated an ICF, approved by an IRB/IEC and provided HIPAA (or applicable privacy regulation) authorization prior to any participation in the study.
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 (including over the counter), prebiotics, probiotics, home remedies, herbal preparations or rehydration fluids that might affect GI tolerance. * Participant participates in another study that has not been approved as a concomitant study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weight | Day of life 14 to Day of life 119 | Weight gain per day |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Head Circumference (HC) | Day of life 14 to Day of life 119 | HC gain per day |
| Stool Characteristics | Study Day 1 to Day of life 119 | Parent completed diary |
| Formula Tolerance | Study Day 1 to Day of life 119 | Parent completed diary |
| Length | Day of life 14 to Day of life 119 | Length gain per day |
Other
| Measure | Time frame | Description |
|---|---|---|
| Infant and Household Characteristics | Study Day 1 to Day of Life 119 | Parent reported lifestyle and illness questions |
| Infant Feeding and Stool Patterns Questionnaire | Exit or Day of life 119 | Parent completed questionnaire; 16, 5-point Likert scale questions, scaled in the negative direction |
| Infant Behavior Questionnaire | Exit or Day of life 42 to Day of life 119 | Parent completed questionnaire; 22 questions with 5-point Likert scale questions, scaled in the negative direction |
| Formula Satisfaction Questionnaire | Exit or Day of life 119 | Parent completed questionnaire; 12 questions with 5-point Likert scale questions scaled in the negative direction |
Countries
United States
Outcome results
None listed