Evaluation of Preterm Infants Fed Post-Discharge Preterm Infant Formula

NCT03991949 | Completed

• 1 other identifier: AL35
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 7

Brief Summary

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

Conditions

Infant Development

Outcome Measures

Primary Outcomes (1)

• Weight

  Change in weight-for-age z-score

  SDAY 1 to SDAY 56

Secondary Outcomes (4)

• Stool Characteristics

  Study Day (SDAY) 1 to SDAY 56

• Formula Intake

  SDAY 1 to SDAY 56

• Length

  SDAY 1 to SDAY 56

• Head Circumference

  SDAY 1 to SDAY 56

Study Arms (1)

Experimental Infant Formula

EXPERIMENTAL

Ready-to-feed, milk-based formula

Other: Experimental Infant Formula

Interventions

Experimental Infant Formula OTHER

Formula fed Ad libitum

Experimental Infant Formula

Eligibility Criteria

• Age: 34 Weeks - 41 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

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

Sponsors & Collaborators

• Abbott Nutrition: lead

Study Sites (7)

University of South Florida

Tampa, Florida, 33606, United States

Location

University of Louisville Research Foundation, Inc.

Louisville, Kentucky, 40202, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

Location

The Cleveland Pediatric Research Center, LLC

Middleburg Heights, Ohio, 44130, United States

Location

Women's Hospital at Renaissance - Doctors Hospital at Renaissance

Edinburg, Texas, 78539, United States

Location

Maximos Ob/Gyn

League City, Texas, 77573, United States

Location

Study Officials

• Michelle Johnson, RDN, LD

  Abbott Nutrition

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2019
• First Posted: June 19, 2019
• Study Start: October 4, 2019
• Primary Completion: November 16, 2022
• Study Completion: November 16, 2022
• Last Updated: December 13, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)