Breast-milk Enema Administration to Stimulate Passage of Meconium
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: breast milk.
- Who it may be relevant to
- Registry conditions: Breast-milk. Basic parameters: 23 Weeks — 28 Weeks · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Breast-Milk Enema Administration to Stimulate Meconium Passage in Preterm Infants
Overview
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
Detailed description
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.
Interventions
- Drug 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.
Primary outcome measures
- Recruitment rate [Time frame: Day 1]
- Protocol adherence rate [Time frame: Day 1]
- Incidence of necrotizing enterocolitis (NEC) [Time frame: Day 14]
- Incidence of culture proven sepsis [Time frame: Day 7]
- Incidence of rectal or gastrointestinal injury [Time frame: Day 7]
Secondary outcome measures (5)
- Time to achieve full enteral feeds [Time frame: Day 14]
- Duration of parenteral nutrition [Time frame: Day 14]
- Time to first stool following intervention [Time frame: Day 7]
- Total length of hospital stay [Time frame: Day 120]
- Number of central line days [Time frame: Day 120]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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
- significant hematologic abnormalities such as neutropenia or thrombocytopenia.
- Infants will also be excluded in the absence of written informed consent from a parent or legal guardian.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 1 center
- Wake Forest University Health Sciences — Winston-Salem
Identifiers
NCT: NCT07661992 · IRB00150290