Infant Development
Conditions
Brief summary
This single-group study will assess growth and tolerance of infants fed a post-discharge preterm infant formula containing a prebiotic.
Interventions
Formula fed Ad libitum
Sponsors
Abbott Nutrition
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
34 Weeks to 41 Weeks
Healthy volunteers
Yes
Inclusion criteria
* Gestational age at birth less than 37 weeks * Birth weight less than 3200 g (approximately 7 pounds) * Postmenstrual age is 34 0/7 through 41 0/7 weeks at enrollment * Parent(s) confirm their intention to feed their infant the study product as the sole source of nutrition for the duration of the study * The currently-fed formula is a milk-based infant formula at a caloric density of ≤ 24 Cal/fl oz. * Singleton, twin, or triplet births only. * Parent(s) confirm their intention not to administer solid foods or juices to their infant from enrollment through the duration of the study, unless instructed otherwise by their healthcare professional. * Participant's parent(s) has voluntarily signed and dated an ICF, approved by an IRB/IEC and provided HIPAA (or other 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, home remedies, herbal preparations, prebiotics or probiotics, rehydration solutions, or parenteral nutrition * Participant is known to require elective surgery with hospitalization, other than uncomplicated outpatient surgery, during the course of the study. * Participant is in another study that has not been approved as a concomitant study * Participant has an allergy or intolerance to any ingredient in the study product * Participant is currently receiving oxygen therapy * Participant is currently receiving antibiotics * Participant is currently receiving tube feedings
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weight | SDAY 1 to SDAY 56 | Change in weight-for-age z-score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stool Characteristics | Study Day (SDAY) 1 to SDAY 56 | Parent completed diary |
| Formula Intake | SDAY 1 to SDAY 56 | Parent completed diary |
| Length | SDAY 1 to SDAY 56 | Interval length gain per day |
| Head Circumference | SDAY 1 to SDAY 56 | Interval HC gain per day |
Countries
United States
Outcome results
None listed