Evaluation of Preterm Infants Fed Post-Discharge Preterm Infant Formula

Completed · Not applicable

Conditions studied: Infant Development

In brief

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

Key facts

Study ID

NCT03991949

Run by

Abbott Nutrition

People needed

51

Starts

2019-10-04

Expected to finish

2022-11-16

Last updated by the study team

2022-12-13

Who can join

Age: 1 and older, up to 1. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• University of South Florida — Tampa, Florida, United States
• University of Louisville Research Foundation, Inc. — Louisville, Kentucky, United States
• University of Mississippi Medical Center — Jackson, Mississippi, United States
• MetroHealth Medical Center — Cleveland, Ohio, United States
• The Cleveland Pediatric Research Center, LLC — Middleburg Heights, Ohio, United States
• Women's Hospital at Renaissance - Doctors Hospital at Renaissance — Edinburg, Texas, United States
• Maximos Ob/Gyn — League City, Texas, United States

Full record on ClinicalTrials.gov

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