Transition From Donor Milk: a Feasibility Study

Not Applicable

Recruiting

• Conditions: Nutrition, Healthy; Preterm Birth

• Registration Number: NCT06514014
• Lead Sponsor: Augusta University

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 available

Study Timeline

• Study First Submitted: 2024-07-17
• Study First Submitted QC: 2024-07-17
• Study First Posted: 2024-07-23
• Status Verified: 2025-04
• Study Start: 2025-05-01
• Last Update Submitted: 2025-08-19
• Last Update Posted: 2025-08-24
• Primary Completion: 2026-12-31
• Study Completion: 2027-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Weight Velocity	36 weeks post menstrual age	Weight velocity between birth and 36 weeks post menstrual age
Fat free mass	36 weeks post menstrual age	Fat free mass at 36 weeks post menstrual age

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Wellstar-MCG; 🇺🇸 Augusta, Georgia, United States