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Purpose

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

Condition

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.