Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157, United States
NCT Number: NCT07661992
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 opening soon.
Get Notified23 week–28 week
All sexes
Interventional
Phase 1
Winston-Salem, North Carolina, 27157, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Day 1
Recruitment rate
Time frame: Day 1
Protocol adherence rate
Time frame: Day 14
Incidence of necrotizing enterocolitis (NEC)
Time frame: Day 7
Incidence of culture proven sepsis
Time frame: Day 7
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.
Time frame: Day 14
Enteral feeds (enteral nutrition or tube feeding) times
Time frame: Day 14
Parenteral nutrition (PN) is a method of delivering essential nutrients directly into the bloodstream through an intravenous (IV) catheter.
Time frame: Day 7
Time to first stool following intervention
Time frame: Day 120
Total length of hospital stay
Time frame: Day 120
Number of central line days
Contact information is provided by the study sponsor or research team.
Wake Forest University Health Sciences
Other
Breast-Milk Enema Administration to Stimulate Meconium Passage in Preterm Infants
Acronym: BEAM
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