Evaluation of Preterm Infants Fed Post-Discharge Preterm Infant Formula

Infant Development Clinical Trial

Official title:

Evaluation of Preterm Infants Fed Post-Discharge Preterm Infant Formula With Prebiotic

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03991949
• Other study ID #: AL35
• Status: Completed
• Phase: N/A
• Start date: October 4, 2019
• Est. completion date: November 16, 2022

Study information

• Verified date: December 2022
• Source: Abbott Nutrition
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: November 16, 2022
• Est. primary completion date: November 16, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 34 Weeks to 41 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Infant Development
• Premature Birth

Intervention

Other:
• Experimental Infant Formula
Formula fed Ad libitum

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Nutrition

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight	Change in weight-for-age z-score	SDAY 1 to SDAY 56
Secondary	Stool Characteristics	Parent completed diary	Study Day (SDAY) 1 to SDAY 56
Secondary	Formula Intake	Parent completed diary	SDAY 1 to SDAY 56
Secondary	Length	Interval length gain per day	SDAY 1 to SDAY 56
Secondary	Head Circumference	Interval HC gain per day	SDAY 1 to SDAY 56