Breast-milk Enema Administration to Stimulate Passage of Meconium (NCT07661992) | Clinical Trial Compass
Not Yet RecruitingPhase 1
Breast-milk Enema Administration to Stimulate Passage of Meconium
United States20 participantsStarted 2026-07
Plain-language summary
Lack of passage of meconium in preterm infants delays feeding advancement and may represent a risk factor for necrotizing enterocolitis (NEC) and spontaneous intestinal perforation (SIP). Usual management of meconium impaction has included glycerin suppositories and normal saline enemas. Various methods are used in routine neonatal care to promote meconium evacuation; however, there is no consensus on the agents used and the frequency of applications
Who can participate
Age range
23 Weeks – 28 Weeks
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.