Evaluation of Preterm Infants Fed Post-Discharge Preterm Infant Formula
NCT ID: NCT03991949
Last Updated: 2022-12-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
51 participants
INTERVENTIONAL
2019-10-04
2022-11-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Experimental Infant Formula
Ready-to-feed, milk-based formula
Experimental Infant Formula
Formula fed Ad libitum
Interventions
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Experimental Infant Formula
Formula fed Ad libitum
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
34 Weeks
41 Weeks
ALL
Yes
Sponsors
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Abbott Nutrition
INDUSTRY
Responsible Party
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Principal Investigators
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Michelle Johnson, RDN, LD
Role: STUDY_CHAIR
Abbott Nutrition
Locations
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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
Countries
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Other Identifiers
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AL35
Identifier Type: -
Identifier Source: org_study_id