Breast-milk Enema Administration to Stimulate Passage of Meconium

NCT07661992 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: IRB00150290
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Breast-milk

Keywords

Meconium; rectal enemas; low birth weight infants

Outcome Measures

Primary Outcomes (5)

• Recruitment rate

  Recruitment rate

  Day 1

• Protocol adherence rate

  Protocol adherence rate

  Day 1

• Incidence of necrotizing enterocolitis (NEC)

  Incidence of necrotizing enterocolitis (NEC)

  Day 14

• Incidence of culture proven sepsis

  Incidence of culture proven sepsis

  Day 7

• Incidence of rectal or gastrointestinal injury

  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.

  Day 7

Secondary Outcomes (5)

• Time to achieve full enteral feeds

  Day 14

• Duration of parenteral nutrition

  Day 14

• Time to first stool following intervention

  Day 7

• Total length of hospital stay

  Day 120

• Number of central line days

  Day 120

Study Arms (1)

breast milk

EXPERIMENTAL

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. The prescribed enema volume (5 mL/kg) will be calculated based on current weight and warmed to 37 °C using an approved breast milk warmer.

Drug: breast milk

Interventions

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.

breast milk

Eligibility Criteria

• Age: 23 Weeks - 28 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Interventions

Milk, Human

Intervention Hierarchy (Ancestors)

Milk; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Dairy Products; Food; Food and Beverages

Study Officials

• Ricardo J Rodriquez, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Monica C Gierbolini Collazo, MD

CONTACT

787-239-6289; monica.gierbolinicollazo@advocatehelth.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Preterm infants born at \>23 0/7 and \<28 0/7 weeks' gestational age

Study Record Dates

• First Submitted: June 17, 2026
• First Posted: June 23, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: July 28, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)