Breast-milk Enema Administration to Stimulate Passage of Meconium (BEAM)

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Breast-milk
• Intervention / Treatment: Drug: breast milk

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Monica C Gierbolini Collazo, MD; Phone Number: 787-239-6289; Email: monica.gierbolinicollazo@advocatehelth.org

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University Health Sciences
      • Contact: Monica C Gierbolini Collazo, MD; Phone Number: 787-239-6289; Email: monica.gierbolinicollazo@advocatehelth.org,

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: breast milk; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to achieve full enteral feeds	Enteral feeds (enteral nutrition or tube feeding) times	Day 14
Duration of parenteral nutrition	Parenteral nutrition (PN) is a method of delivering essential nutrients directly into the bloodstream through an intravenous (IV) catheter.	Day 14
Time to first stool following intervention	Time to first stool following intervention	Day 7
Total length of hospital stay	Total length of hospital stay	Day 30
Number of central line days	Number of central line days	Day 30

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Principal Investigator: Ricardo J Rodriquez, MD, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: June 17, 2026
• First Submitted That Met QC Criteria: June 17, 2026
• First Posted (Actual): June 23, 2026

Study Record Updates

• Last Update Posted (Actual): June 23, 2026
• Last Update Submitted That Met QC Criteria: June 17, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Meconium; low birth weight infants; rectal enemas
• Additional Relevant MeSH Terms: Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Beverages; Dairy Products; Milk; Milk, Human
• Other Study ID Numbers: IRB00150290

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No