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Breast-milk Enema for Preterm Infants with Delayed Meconium Passage

This study is looking at whether giving a small enema of a mother's own breast milk can help very premature babies (born between 23 and 28 weeks of pregnancy) pass their first stool (meconium) if they haven't done so within 48 hours of birth. Delayed meconium passage can cause problems like necrotizing enterocolitis (NEC), a serious gut condition. Researchers believe breast milk might soften the meconium and help the baby's intestines move it along. The study will measure how many babies are recruited, how well the study plan is followed, and if there's any change in the rate of NEC. This study plans to enroll 20 babies and its current status is unclear.

Study design
This is an interventional study with an unspecified phase, planning to enroll 20 participants. It involves giving breast milk as an enema.
What's involved
You would need to provide consent for your baby to receive a small breast milk enema, possibly with one repeat dose after 24 hours if needed. Your baby must be born at Atrium Health Wake Forest Baptist Hospital or transferred there within 24 hours of birth, and your own breast milk must be available.
Compensation
Not stated in the trial record.
Follow-up
The study will track the incidence of necrotizing enterocolitis (NEC) for 14 days after the intervention.

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NCT07661992

Breast-milk Enema Administration to Stimulate Passage of Meconium

Not Yet Recruiting
PHASE1Ages 23–28InterventionalPrevention
Wake Forest University Health Sciences
~20 participants
Updated 2026-07-28 on ClinicalTrials.gov
What's tested:breast milk

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Recruitment rate
Measured over Day 1
+4 more outcomes measured

Conditions

Breast-milk

Explore related trials

Meconium ImpactionPremature infant

Where it's being run

1 sites across 1 states
North Carolina1

Study leadership

  • Ricardo J Rodriquez, MD · PRINCIPAL_INVESTIGATOR · Wake Forest University Health Sciences

Who to contact

Monica C Gierbolini Collazo, MD
[email protected]
787-239-6289
Email the study team

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Recruitment rateDay 1

    Recruitment rate

  • Protocol adherence rateDay 1

    Protocol adherence rate

  • Incidence of necrotizing enterocolitis (NEC)Day 14

    Incidence of necrotizing enterocolitis (NEC)

  • Incidence of culture proven sepsisDay 7

    Incidence of culture proven sepsis

  • Incidence of rectal or gastrointestinal injuryDay 7

    Incidence of rectal or gastrointestinal injury - Rectal trauma will be assessed clinically by the presence of bleeding, fissure, or other visible anorectal injury on physical examination.