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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
breast milk
DrugA 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.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: breast milkExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Recruitment rate
Recruitment rate
Time frame
Day 12
Protocol adherence rate
Protocol adherence rate
Time frame
Day 13
Incidence of necrotizing enterocolitis (NEC)
Incidence of necrotizing enterocolitis (NEC)
Time frame
Day 144
Incidence of culture proven sepsis
Incidence of culture proven sepsis
Time frame
Day 7Secondary outcomes
1
Time to achieve full enteral feeds
Enteral feeds (enteral nutrition or tube feeding) times
Time frame
Day 142
Duration of parenteral nutrition
Parenteral nutrition (PN) is a method of delivering essential nutrients directly into the bloodstream through an intravenous (IV) catheter.
Time frame
Day 143
Time to first stool following intervention
Time to first stool following intervention
Time frame
Day 74
Total length of hospital stay
Total length of hospital stay
Time frame
Day 120Sponsors and contacts
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Source ClinicalTrials.gov
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