Evaluation of Preterm Infants Fed Post-Discharge Preterm Infant Formula

Study Overview
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Brief Summary
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This single-group study will assess growth and tolerance of infants fed a post-discharge preterm infant formula containing a prebiotic.

Official Title
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Evaluation of Preterm Infants Fed Post-Discharge Preterm Infant Formula With Prebiotic

Conditions
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Infant Development

Intervention / Treatment
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* Other: Experimental Infant Formula


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 34 Weeks
Maximum Age: 41 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Infant Formula<br>Ready-to-feed, milk-based formula | Other: Experimental Infant Formula<br>* Formula fed Ad libitum<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight | Change in weight-for-age z-score | SDAY 1 to SDAY 56 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stool Characteristics | Parent completed diary | Study Day (SDAY) 1 to SDAY 56 | 
| Formula Intake | Parent completed diary | SDAY 1 to SDAY 56 | 
| Length | Interval length gain per day | SDAY 1 to SDAY 56 | 
| Head Circumference | Interval HC gain per day | SDAY 1 to SDAY 56 |