Breast-milk
Conditions
Keywords
Meconium, rectal enemas, low birth weight infants
Brief summary
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
DRUGbreast 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.
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Preterm infants born at \>23 0/7 and \<28 0/7 weeks' gestational age
Eligibility
Sex/Gender
ALL
Age
23 Weeks to 28 Weeks
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment rate | Day 1 | Recruitment rate |
| Protocol adherence rate | Day 1 | Protocol adherence rate |
| Incidence of necrotizing enterocolitis (NEC) | Day 14 | Incidence of necrotizing enterocolitis (NEC) |
| Incidence of culture proven sepsis | Day 7 | Incidence of culture proven sepsis |
| Incidence of rectal or gastrointestinal injury | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to achieve full enteral feeds | Day 14 | Enteral feeds (enteral nutrition or tube feeding) times |
| Duration of parenteral nutrition | Day 14 | Parenteral nutrition (PN) is a method of delivering essential nutrients directly into the bloodstream through an intravenous (IV) catheter. |
| Time to first stool following intervention | Day 7 | Time to first stool following intervention |
| Total length of hospital stay | Day 120 | Total length of hospital stay |
| Number of central line days | Day 120 | Number of central line days |
Countries
United States
Contacts
CONTACTMonica C Gierbolini Collazo, MD
PRINCIPAL_INVESTIGATORRicardo J Rodriquez, MD
Wake Forest University Health Sciences
Outcome results
None listed