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Recruiting NCT06514014

Transition From Donor Milk: a Feasibility Study

No phase Interventional Preterm Birth Nutrition, Healthy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Preterm Infant Formula.
Who it may be relevant to
Registry conditions: Preterm Birth, Nutrition, Healthy. Basic parameters: from 28 Days · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Dietary supplement Preterm Infant Formula
    Transition from donor human milk to preterm infant formula

Primary outcome measures

  • Weight Velocity [Time frame: 36 weeks post menstrual age]
  • Fat free mass [Time frame: 36 weeks post menstrual age]
Secondary outcome measures (4)
  • Number of Patients with Bronchopulmonary dysplasia [Time frame: 36 weeks post menstrual age]
  • Number of Patients with Retinopathy of prematurity [Time frame: 36 weeks post menstrual age]
  • Number of Patients with Sepsis [Time frame: 36 weeks post menstrual age]
  • Number of Patients with Necrotizing enterocolitis [Time frame: 36 weeks post menstrual age]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Wellstar-MCG — Augusta

Identifiers

NCT: NCT06514014 · 2193903

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗