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Trial record 1 of 1 for:    03991949
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Evaluation of Preterm Infants Fed Post-Discharge Preterm Infant Formula

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03991949
Recruitment Status : Recruiting
First Posted : June 19, 2019
Last Update Posted : June 28, 2022
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Infant Development Other: Experimental Infant Formula Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 62 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Evaluation of Preterm Infants Fed Post-Discharge Preterm Infant Formula With Prebiotic
Actual Study Start Date : October 4, 2019
Estimated Primary Completion Date : July 2023
Estimated Study Completion Date : July 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Experimental Infant Formula
Ready-to-feed, milk-based formula
Other: Experimental Infant Formula
Formula fed Ad libitum




Primary Outcome Measures :
  1. Weight [ Time Frame: SDAY 1 to SDAY 56 ]
    Change in weight-for-age z-score


Secondary Outcome Measures :
  1. Stool Characteristics [ Time Frame: Study Day (SDAY) 1 to SDAY 56 ]
    Parent completed diary

  2. Formula Intake [ Time Frame: SDAY 1 to SDAY 56 ]
    Parent completed diary

  3. Length [ Time Frame: SDAY 1 to SDAY 56 ]
    Interval length gain per day

  4. Head Circumference [ Time Frame: SDAY 1 to SDAY 56 ]
    Interval HC gain per day



Information from the National Library of Medicine

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Ages Eligible for Study:   34 Weeks to 41 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03991949


Contacts
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Contact: Kristen DeLuca, MS, RDN, LD 614-624-5455 kristen.deluca@abbott.com

Locations
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United States, Alabama
Alabama Clinical Therapeutics, LLC Withdrawn
Birmingham, Alabama, United States, 35205
United States, District of Columbia
Georgetown University Medical Center Recruiting
Washington, District of Columbia, United States, 20007
United States, Florida
University Clinical Research-Deland, LLC; Accel Clinical Research Withdrawn
Orlando, Florida, United States, 32829
University of South Florida Recruiting
Tampa, Florida, United States, 33606
United States, Iowa
University of Iowa Stead Family Children's Hospital Withdrawn
Iowa City, Iowa, United States, 52242
United States, Kentucky
University of Louisville Research Foundation, Inc. Recruiting
Louisville, Kentucky, United States, 40202
United States, Mississippi
University of Mississippi Medical Center Recruiting
Jackson, Mississippi, United States, 39216
United States, Missouri
Children's Mercy Recruiting
Kansas City, Missouri, United States, 64108
United States, Ohio
MetroHealth Medical Center Recruiting
Cleveland, Ohio, United States, 44109
The Cleveland Pediatric Research Center, LLC Completed
Middleburg Heights, Ohio, United States, 44130
United States, Tennessee
Holston Medical Group Withdrawn
Kingsport, Tennessee, United States, 37660
United States, Texas
Women's Hospital at Renaissance - Doctors Hospital at Renaissance Recruiting
Edinburg, Texas, United States, 78539
Ventavia Research Group Withdrawn
Houston, Texas, United States, 77008
Maximos Ob/Gyn Recruiting
League City, Texas, United States, 77573
Sponsors and Collaborators
Abbott Nutrition
Investigators
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Study Chair: Michelle Johnson, RDN, LD Abbott Nutrition
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Responsible Party: Abbott Nutrition
ClinicalTrials.gov Identifier: NCT03991949    
Other Study ID Numbers: AL35
First Posted: June 19, 2019    Key Record Dates
Last Update Posted: June 28, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications