Evaluation of Preterm Infants Fed Post-Discharge Preterm... | NCT03991949

Studies
Evaluation of Preterm Infants Fed Post-Discharge Preterm Infant Formula

NCT03991949

Sponsor

Abbott Nutrition

Status

Completed

Last Update Posted

Dec 13, 2022Actual

Enrollment

51Actual

Phase

Not Applicable

Conditions

Infant Development

Interventions

Experimental Infant Formula

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 4, 2019Actual

Primary Completion Date

Nov 16, 2022Actual

Completion Date

Nov 16, 2022Actual

First Submitted Date

Jun 18, 2019

First Submission Date that Met QC Criteria

Jun 18, 2019

First Posted Date

Jun 19, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 12, 2022

Last Update Posted Date

Dec 13, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

51Actual

Label	Type	Description	Intervention Names
Experimental Infant Formula	Experimental	Ready-to-feed, milk-based formula	Other: Experimental Infant Formula

Name	Type	Description	Arm Group Labels	Other Names
Experimental Infant Formula	Other	Formula fed Ad libitum	Experimental Infant Formula

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Weight	Change in weight-for-age z-score	SDAY 1 to SDAY 56

Secondary Outcomes

Measure	Description	Time Frame
Stool Characteristics	Parent completed diary	Study Day (SDAY) 1 to SDAY 56
Formula Intake	Parent completed diary	SDAY 1 to SDAY 56

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

34 Weeks

Maximum Age

41 Weeks

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
University of South Florida		Tampa	Florida	33606	United States
University of Louisville Research Foundation, Inc.