Breast-Milk enema: a natural boost for tiny babies?
NCT ID NCT07661992
First seen Jun 25, 2026 · Last updated Jul 29, 2026 · Updated 5 times
Summary
This early-phase trial tests whether a small enema made from the mother's own breast milk can help very preterm infants (born before 28 weeks) pass their first stool (meconium). Delayed passage can slow feeding and raise the risk of serious gut infections. The study will enroll 20 infants and check safety, including any injury or infection, as well as how well the enema works.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- breast milk
- What this could lead to
- If it works, this could offer a simple, natural way to help preterm infants pass their first stool, potentially reducing feeding delays and serious gut problems.
- What could go wrong
- This is a very early, small phase 1 trial with only 20 infants, so results may not apply widely. There are also risks like infection or rectal injury from the enema.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2026
An estimate. Start dates often move.
- Expected to finish
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Jul 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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23 to 28 weeks
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Preterm infants born at \>23 and \<28 weeks' gestational age born at Atrium Health Wake Forest Baptist Hospital or transferred in the first 24 hours of life. * postnatal age \>48 hours, absence of spontaneous passage of meconium by \>48 hours of life * availability of mother's own milk * written informed consent obtained from a parent or legal guardian. Exclusion Criteria: * Infants with Necrotizing Enterocolitis (NEC) ≥ stage II * spontaneous intestinal perforation (SIP) * gastrointestinal or anorectal malformations * infants that have developed severe hemodynamic instability or sepsis with need for vasoactive drugs * significant hematologic abnormalities such as neutropenia or thrombocytopenia. * Infants will also be excluded in the absence of written informed consent from a parent or legal guardian.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157, United States
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