Evaluation of Preterm Infants Fed Post-Discharge Preterm Infant Formula

Purpose

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

Condition

  • Infant Development

Eligibility

Eligible Ages
Between 34 Weeks and 41 Weeks
Eligible Genders
All
Accepts 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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Other
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Experimental Infant Formula 		Ready-to-feed, milk-based formula
  • Other: Experimental Infant Formula
    Formula fed Ad libitum

More Details

Status
Completed
Sponsor
Abbott Nutrition

Study Contact