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NCT Number: NCT07661992

Breast-milk Enema Administration to Stimulate Passage of Meconium

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

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Key information

Conditions

Age range

23 week–28 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location contact

Monica C Gierbolini Collazo, MD

CONTACT

[email protected],

787-239-6289

About this study

Breast milk is a natural oil-in-water emulsion that can soften meconium, lubricate, and stimulate the intestinal wall, making it easier to excrete meconium. The osmotic pressure of breast milk is a benign stimulus to the digestive tract of premature infants. In addition, breast milk contains bioactive compounds that may positively influence gut motility and the microbiome and has been shown to decrease the incidence of NEC. A small-volume rectal enemas using mother's own breast milk in preterm infants born at <28 weeks' gestation with delayed passage of meconium (>48 hours of life) are feasible and safe, and may be associated with earlier meconium passage and improved early feeding outcomes without increasing the risk of necrotizing enterocolitis (NEC) or other gastrointestinal complications.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

breast milk

Drug

A small-volume rectal enema consisting of 5 mL/kg of fresh mother's own breast milk will be administered as a single dose, with the option for one repeat dose at 24 hours if clinically indicated.

Primary outcomes

  1. Recruitment rate

    Time frame: Day 1

    Recruitment rate

  2. Protocol adherence rate

    Time frame: Day 1

    Protocol adherence rate

  3. Incidence of necrotizing enterocolitis (NEC)

    Time frame: Day 14

    Incidence of necrotizing enterocolitis (NEC)

  4. Incidence of culture proven sepsis

    Time frame: Day 7

    Incidence of culture proven sepsis

  5. Incidence of rectal or gastrointestinal injury

    Time frame: Day 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.

Secondary outcomes

  1. Time to achieve full enteral feeds

    Time frame: Day 14

    Enteral feeds (enteral nutrition or tube feeding) times

  2. Duration of parenteral nutrition

    Time frame: Day 14

    Parenteral nutrition (PN) is a method of delivering essential nutrients directly into the bloodstream through an intravenous (IV) catheter.

  3. Time to first stool following intervention

    Time frame: Day 7

    Time to first stool following intervention

  4. Total length of hospital stay

    Time frame: Day 120

    Total length of hospital stay

  5. Number of central line days

    Time frame: Day 120

    Number of central line days

Study contacts

Contact information is provided by the study sponsor or research team.

Monica C Gierbolini Collazo, MD

CONTACT

[email protected]

787-239-6289

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Official study title

Breast-Milk Enema Administration to Stimulate Meconium Passage in Preterm Infants

Acronym: BEAM

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 23, 2026
Registry last updated
Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.