Preterm BirthNCT05228535
Human Milk in Preterm Infants
A study testing Human milk fortifier in people with Preterm Birth, run by Augusta University at 1 site in United States.
Trial summary
Current NICU protocol introduces human milk fortifier at 8 days of feeding. This study will introduce human milk fortifier at day 1. The primary outcome is the effect on growth velocity at 28 days and 36 weeks post menstrual age. Read more about this study
- Who is it for?
- Ages Up to 4 daysHealthy volunteers can take part
- Conditions the study is for
- Preterm Birth
- What is being tested?
- Human milk fortifier
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Apr 2022to Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Up to 4 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Birth weight 1000-1500 grams
- Admitted to NICU within 24 hours of life
- Maternal intent to use human milk
Who cannot join
- Congenital anomalies
- Feeds not started within the first 96 hours of life
- Intrauterine growth restriction
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Children's Hospital of Georgia
Augusta, Georgia, 30912
Zanna Wynter, DO, zwynter@augusta.edu
About this study
Official title: Early Fortification of Human Milk for Very Low Birth Weight Infants and Effects on Growth Velocity
Current NICU protocol introduces human milk fortifier at 8 days of feeding. This study will introduce human milk fortifier at day 1. The primary outcome is the effect on growth velocity at 28 days and 36 weeks post menstrual age.
- Conditions
- Preterm Birth
- Being tested
- Human milk fortifier
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human milk fortifierDietary supplement
Human milk fortifier added to human breast milk at day 1 vs day 8 of feeds
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Continue current NICU feeding protocol, introducing human milk fortifier at 8 days |
| Intervention | Experimental | Introducing human milk fortifier at 1 day Receives: Dietary Supplement: Human milk fortifier |
What is being measured
The primary outcome is the main question the study is designed to answer.
Growth velocity
weight gain in grams/kg/day
Measured: at 28 days of life
Secondary outcomes (1)
Growth velocity
weight gain in grams/kg/day
Measured: at 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 posted8 Feb 2022
- Study start11 Apr 2022
- Primary completionJul 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2 groups. 1 group will be controlled, following standard NICU feeding protocol. 1 group will be intervention, receiving early introduction of human milk fortifier to enteral feeds.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Augusta University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05228535
- Sponsor's protocol ID
- 1813934-2
- Status last verified
- Jul 2022
- First submitted
- 14 Jan 2022
- Last updated
- 21 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wynter Z, Gorham JA, Thompson AB, Mundy C, Waller JL, Stansfield BK. Immediate fortification of human milk with a bovine milk-derived human milk fortifier in very low birth weight infants: a randomized clinical trial. J Perinatol. 2024 Nov;44(11):1591-1596. doi: 10.1038/s41372-024-01998-0. Epub 2024 May 9.
PubMed 38724605
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Fortification of Human Milk for Very Low Birth Weight Infants and Effects on Growth Velocity
- ClinicalTrials.gov ID
- NCT05228535
- Acronym / sponsor ID
- 1813934-2
- Conditions
- Preterm Birth
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Augusta UniversityUniversity, hospital or other
- Study start
- 11 Apr 2022 (actual)
- Primary completion
- Jul 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 8 Feb 2022 (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.
Current NICU protocol introduces human milk fortifier at 8 days of feeding. This study will introduce human milk fortifier at day 1. The primary outcome is the effect on growth velocity at 28 days and 36 weeks post menstrual age.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 2 groups. 1 group will be controlled, following standard NICU feeding protocol. 1 group will be intervention, receiving early introduction of human milk fortifier to enteral feeds.
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Continue current NICU feeding protocol, introducing human milk fortifier at 8 days |
| Intervention | Experimental | Dietary Supplement: Human milk fortifierIntroducing human milk fortifier at 1 day |
Who may qualify
- Ages
- Up to 4 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Birth weight 1000-1500 grams
- Admitted to NICU within 24 hours of life
- Maternal intent to use human milk
Key exclusion criteria (3 listed)
- Congenital anomalies
- Feeds not started within the first 96 hours of life
- Intrauterine growth restriction
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 |
|---|---|---|
| Human milk fortifierHuman milk fortifier added to human breast milk at day 1 vs day 8 of feeds | Dietary supplement | Intervention |
Primary outcome
Growth velocity
Time frame: at 28 days of life
weight gain in grams/kg/day
1 secondary outcome
Growth velocity
Time frame: at 36 weeks post menstrual age
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2022.
- Derived from this study: PubMed 38724605Wynter Z, Gorham JA, Thompson AB, Mundy C, Waller JL, Stansfield BK. Immediate fortification of human milk with a bovine milk-derived human milk fortifier in very low birth weight infants: a randomized clinical trial. J Perinatol. 2024 Nov;44(11):1591-1596. doi: 10.1038/s41372-024-01998-0. Epub 2024 May 9.
- 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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Human milk fortifier in people with Preterm Birth, 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 3 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: status not confirmed, as of the sponsor's last update on 21 Jul 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zanna Wynter, DO (770-608-0868, zwynter@augusta.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Growth velocity (time frame: at 28 days of life). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05228535, which also lists 1 linked publication.
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 21 Jul 2022.