Breast-milk Enema Administration to Stimulate Passage of Meconium
ConditionBreast-milk
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age23-28
SponsorWake Forest University Health Sciences
About this trial
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
Eligibility criteria
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- breast milk
Treatment groups
20 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov