Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06514014

Transition From Donor Milk: a Feasibility Study

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Preterm Birth Female Urogenital Diseases and Pregnancy Complications Nutrition, Healthy Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

28 day and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wellstar-MCG

Augusta, Georgia, 30912, United States

Location status: Recruiting

Location contact

Brian Stansfield, MD

CONTACT

[email protected]

706-721-2331

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Preterm Infant Formula

Dietary Supplement

Transition from donor human milk to preterm infant formula

Primary outcomes

  1. Weight Velocity

    Time frame: 36 weeks post menstrual age

    Weight velocity between birth and 36 weeks post menstrual age

  2. Fat free mass

    Time frame: 36 weeks post menstrual age

    Fat free mass at 36 weeks post menstrual age

Secondary outcomes

  1. Number of Patients with Bronchopulmonary dysplasia

    Time frame: 36 weeks post menstrual age

  2. Number of Patients with Retinopathy of prematurity

    Time frame: 36 weeks post menstrual age

  3. Number of Patients with Sepsis

    Time frame: 36 weeks post menstrual age

  4. Number of Patients with Necrotizing enterocolitis

    Time frame: 36 weeks post menstrual age

Sponsors and collaborators

Lead sponsor

Augusta University

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Jul 23, 2024
Registry last updated
Aug 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.