Back to resultsEvaluation of Preterm Infants Fed Post-Discharge Preterm Infant Formula
Primary Purpose
Infant Development
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Experimental Infant Formula
Sponsored by
About this trial
This is an interventional other trial for Infant Development
Eligibility Criteria
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
Sites / Locations
- University of South Florida
- University of Louisville Research Foundation, Inc.
- University of Mississippi Medical Center
- MetroHealth Medical Center
- The Cleveland Pediatric Research Center, LLC
- Women's Hospital at Renaissance - Doctors Hospital at Renaissance
- Maximos Ob/Gyn
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Experimental Infant Formula
Arm Description
Ready-to-feed, milk-based formula
Outcomes
Primary Outcome Measures
Weight
Change in weight-for-age z-score
Secondary Outcome Measures
Stool Characteristics
Parent completed diary
Formula Intake
Parent completed diary
Length
Interval length gain per day
Head Circumference
Interval HC gain per day
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03991949
Brief Title
Evaluation of Preterm Infants Fed Post-Discharge Preterm Infant Formula
Official Title
Evaluation of Preterm Infants Fed Post-Discharge Preterm Infant Formula With Prebiotic
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
October 4, 2019 (Actual)
Primary Completion Date
November 16, 2022 (Actual)
Study Completion Date
November 16, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Nutrition
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This single-group study will assess growth and tolerance of infants fed a post-discharge preterm infant formula containing a prebiotic.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infant Development
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
51 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental Infant Formula
Arm Type
Experimental
Arm Description
Ready-to-feed, milk-based formula
Intervention Type
Other
Intervention Name(s)
Experimental Infant Formula
Intervention Description
Formula fed Ad libitum
Primary Outcome Measure Information:
Title
Weight
Description
Change in weight-for-age z-score
Time Frame
SDAY 1 to SDAY 56
Secondary Outcome Measure Information:
Title
Stool Characteristics
Description
Parent completed diary
Time Frame
Study Day (SDAY) 1 to SDAY 56
Title
Formula Intake
Description
Parent completed diary
Time Frame
SDAY 1 to SDAY 56
Title
Length
Description
Interval length gain per day
Time Frame
SDAY 1 to SDAY 56
Title
Head Circumference
Description
Interval HC gain per day
Time Frame
SDAY 1 to SDAY 56
10. Eligibility
Sex
All
Minimum Age & Unit of Time
34 Weeks
Maximum Age & Unit of Time
41 Weeks
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michelle Johnson, RDN, LD
Organizational Affiliation
Abbott Nutrition
Official's Role
Study Chair
Facility Information:
Facility Name
University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
University of Louisville Research Foundation, Inc.
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
MetroHealth Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States
Facility Name
The Cleveland Pediatric Research Center, LLC
City
Middleburg Heights
State/Province
Ohio
ZIP/Postal Code
44130
Country
United States
Facility Name
Women's Hospital at Renaissance - Doctors Hospital at Renaissance
City
Edinburg
State/Province
Texas
ZIP/Postal Code
78539
Country
United States
Facility Name
Maximos Ob/Gyn
City
League City
State/Province
Texas
ZIP/Postal Code
77573
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluation of Preterm Infants Fed Post-Discharge Preterm Infant Formula
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