Transition From Donor Milk: a Feasibility Study | NCT06514014

Studies
Transition From Donor Milk: a Feasibility Study

NCT06514014

Sponsor

Augusta University

Status

Recruiting

Last Update Posted

Aug 24, 2025Actual

Enrollment

20Estimated

Phase

Not Applicable

Conditions

Preterm Birth
Nutrition, Healthy

Interventions

Preterm 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

Apr 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2025Actual

Primary Completion Date

Dec 31, 2026Estimated

Completion Date

Jun 30, 2027Estimated

First Submitted Date

Jul 17, 2024

First Submission Date that Met QC Criteria

Jul 17, 2024

First Posted Date

Jul 23, 2024Actual

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

Aug 19, 2025

Last Update Posted Date

Aug 24, 2025Actual

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

Description Module

Brief Summary

Preterm and very low birth weight (VLBW, < 1,500g) infants who receive donor human milk (DHM) often experience slow postnatal growth and no clinical data is available to guide the duration of DHM for preterm infants. The investigators hypothesize that transitioning from DHM to preterm infant formula after the first month of life is both safe and conveys improved weight and length gains and fat free mass accumulation.

Detailed Description

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

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Donor Milk	No Intervention
Preterm Infant Formula	Active Comparator		Dietary Supplement: Preterm Infant Formula

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Preterm Infant Formula	Dietary Supplement	Transition from donor human milk to preterm infant formula	Preterm Infant Formula

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Weight Velocity	Weight velocity between birth and 36 weeks post menstrual age	36 weeks post menstrual age
Fat free mass	Fat free mass at 36 weeks post menstrual age	36 weeks post menstrual age

Secondary Outcomes

Measure	Description	Time Frame
Number of Patients with Bronchopulmonary dysplasia		36 weeks post menstrual age
Number of Patients with Retinopathy of prematurity		36 weeks post menstrual age

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Greater than 1,250 grams
At least 28 days of life
Diet consisting of donor human milk with/without mother's own milk

Exclusion Criteria:

Birth weight below the 5th percentile
History of necrotizing enterocolitis, spontaneous intestinal perforation, or other gastrointestinal disorder
Congenital anomalies
Care team discretion

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

28 Days

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Wellstar-MCG	Recruiting	Augusta	Georgia	30912	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D047928	Premature Birth

Ancestor Terms

ID	Term
D007752	Obstetric Labor, Premature
D007744	Obstetric Labor Complications
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

Not provided

Browse Branches

Not provided