Evaluation of Preterm Infants Fed Post-Discharge Preterm Infant Formula

Not Applicable

Completed

• Conditions: Infant Development
• Interventions: Other: Experimental Infant Formula

• Registration Number: NCT03991949
• Lead Sponsor: Abbott Nutrition

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-06-18
• Study First Submitted QC: 2019-06-18
• Study First Posted: 2019-06-19
• Study Start: 2019-10-04
• Primary Completion: 2022-11-16
• Study Completion: 2022-11-16
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-12
• Last Update Posted: 2022-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental Infant Formula	Experimental Infant Formula	Ready-to-feed, milk-based formula

Primary Outcome Measures

Name	Time	Method
Weight	SDAY 1 to SDAY 56	Change in weight-for-age z-score

Secondary Outcome Measures

Name	Time	Method
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
Stool Characteristics	Study Day (SDAY) 1 to SDAY 56	Parent completed diary

Trial Locations

Locations (7)

University of Mississippi Medical Center; 🇺🇸 Jackson, Mississippi, United States

University of South Florida; 🇺🇸 Tampa, Florida, United States

MetroHealth Medical Center; 🇺🇸 Cleveland, Ohio, United States

Women's Hospital at Renaissance - Doctors Hospital at Renaissance; 🇺🇸 Edinburg, Texas, United States

University of Louisville Research Foundation, Inc.; 🇺🇸 Louisville, Kentucky, United States

The Cleveland Pediatric Research Center, LLC; 🇺🇸 Middleburg Heights, Ohio, United States

Maximos Ob/Gyn; 🇺🇸 League City, Texas, United States