Preterm BirthNCT06514014
Transition From Donor Milk: a Feasibility Study
A study testing Preterm Infant Formula in people with Preterm Birth and Nutrition, Healthy, run by Augusta University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 28 days and older
- Conditions the study is for
- Preterm Birth, Nutrition, Healthy
- What is being tested?
- Preterm Infant Formula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2025to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 28 days and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Greater than 1,250 grams
- At least 28 days of life
- Diet consisting of donor human milk with/without mother's own milk
Who cannot join
- Birth weight below the 5th percentile
- History of necrotizing enterocolitis, spontaneous intestinal perforation, or other gastrointestinal disorder
- Congenital anomalies
- Care team discretion
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Wellstar-MCG
Augusta, Georgia, 30912
Brian Stansfield, MD, 706-721-2331, bstansfield@augusta.edu
About this 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.
- Conditions
- Preterm Birth, Nutrition, Healthy
- Being tested
- Preterm Infant Formula
- Keywords
- newborn, human milk
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preterm Infant FormulaDietary supplement
Transition from donor human milk to preterm infant formula
| Study group | Role | What they receive |
|---|---|---|
| Donor Milk | No intervention | Not described |
| Preterm Infant Formula | Active comparator | Not described Receives: Dietary Supplement: Preterm Infant Formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight Velocity
Weight velocity between birth and 36 weeks post menstrual age
Measured: 36 weeks post menstrual age
Fat free mass
Fat free mass at 36 weeks post menstrual age
Measured: 36 weeks post menstrual age
Secondary outcomes (4)
Number of Patients with Bronchopulmonary dysplasia
Measured: 36 weeks post menstrual age
Number of Patients with Retinopathy of prematurity
Measured: 36 weeks post menstrual age
Number of Patients with Sepsis
Measured: 36 weeks post menstrual age
Number of Patients with Necrotizing enterocolitis
Measured: 36 weeks post menstrual age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2024
- Study start1 May 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm BirthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Open Label Randomized Clinical Trial
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Augusta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brian Stansfield, Augusta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06514014
- Sponsor's protocol ID
- 2193903
- Status last verified
- Apr 2025
- First submitted
- 17 Jul 2024
- Last updated
- 24 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transition From Donor Milk: a Feasibility Study
- ClinicalTrials.gov ID
- NCT06514014
- Acronym / sponsor ID
- 2193903
- Conditions
- Preterm Birth, Nutrition, Healthy
- Keywords
- newborn, human milk
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Augusta UniversityUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 23 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open Label Randomized Clinical Trial
| Arm | Type | Receives |
|---|---|---|
| Donor Milk | No intervention | – |
| Preterm Infant Formula | Active comparator | Dietary Supplement: Preterm Infant Formula |
Who may qualify
- Ages
- 28 days and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Greater than 1,250 grams
- At least 28 days of life
- Diet consisting of donor human milk with/without mother's own milk
Key exclusion criteria (4 listed)
- Birth weight below the 5th percentile
- History of necrotizing enterocolitis, spontaneous intestinal perforation, or other gastrointestinal disorder
- Congenital anomalies
- Care team discretion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Preterm Infant FormulaTransition from donor human milk to preterm infant formula | Dietary supplement | Preterm Infant Formula |
Primary outcome
Weight Velocity
Time frame: 36 weeks post menstrual age
Weight velocity between birth and 36 weeks post menstrual age
Fat free mass
Time frame: 36 weeks post menstrual age
Fat free mass at 36 weeks post menstrual age
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preterm Infant Formula in people with Preterm Birth and Nutrition, Healthy, run by Augusta University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight Velocity (time frame: 36 weeks post menstrual age). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2025.