Transition From Donor Milk: a Feasibility Study

NCT06514014 | Recruiting

• 1 other identifier: 2193903
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Preterm Birth; Nutrition, Healthy

Keywords

newborn; human milk

Outcome Measures

Primary Outcomes (2)

• 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 (4)

• Number of Patients with Bronchopulmonary dysplasia

  36 weeks post menstrual age

• Number of Patients with Retinopathy of prematurity

  36 weeks post menstrual age

• Number of Patients with Sepsis

  36 weeks post menstrual age

• Number of Patients with Necrotizing enterocolitis

  36 weeks post menstrual age

Study Arms (2)

Donor Milk

NO INTERVENTION

Preterm Infant Formula

ACTIVE COMPARATOR

Dietary Supplement: Preterm Infant Formula

Interventions

Preterm Infant Formula DIETARY_SUPPLEMENT

Transition from donor human milk to preterm infant formula

Preterm Infant Formula

Eligibility Criteria

• Age: 28 Days+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Augusta University: lead

Study Sites (1)

Wellstar-MCG

Augusta, Georgia, 30912, United States

RECRUITING

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Vice Chair for Research

Model Details: Open Label Randomized Clinical Trial

Study Record Dates

• First Submitted: July 17, 2024
• First Posted: July 23, 2024
• Study Start: May 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: August 24, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)