Breast-milk Enema Administration to Stimulate Passage of Meconium

Conditions

• Breast-milk

Eligibility Criteria

Sex

ALL

Age

23 Weeks - 28 Weeks

Healthy Volunteers

Not accepted

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.

Study Details

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

Key Dates

Start date

Jul 31, 2026

Status verified

Jun 2026

Primary completion

Dec 31, 2026

Completion

Jan 31, 2027

Study Design

Enrollment

20 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Arms

• 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.

Primary Outcome Measure

Recruitment rate [ Time Frame: Day 1 ]

Central Contacts

• Monica C Gierbolini Collazo, MD
  787-239-6289
  [email protected]

Locations (1)

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