Breast-milk Enema Administration to Stimulate Passage of Meconium

Study acronym: BEAM
StatusNot Yet Recruiting
PhasePhase 1
Started

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Trial flagged as At Risk
Primary completion moved at least 2 months later Dec 2026 → Mar 2027
See other at-risk trials from Wake Forest University Health Sciences

Record History

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  1. Start date: Oct 2026 to Dec 2026
    • Eligibility criteria shortened, about 14 words
    • Study description shortened, about 8 words
  2. Start date: Jul 2026 to Oct 2026
    • Primary completion pushed from Dec 2026 to Mar 2027
    • Study completion pushed from Jan 2027 to Jul 2027
    v3
  3. Secondary endpoints: details revised at 2 of 5 entriesv2
  4. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT07661992
Lead Sponsor Wake Forest University Health Sciences
Conditions
(from sponsor)		 Breast-milk
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov