Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| breast milk | Experimental | 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. The prescribed enema volume (5 mL/kg) will be calculated based on current weight and warmed to 37 °C using an approved breast milk warmer. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| breast milk | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment rate | Recruitment rate | Day 1 |
| Protocol adherence rate | Protocol adherence rate | Day 1 |
| Incidence of necrotizing enterocolitis (NEC) | Incidence of necrotizing enterocolitis (NEC) | Day 14 |
| Incidence of culture proven sepsis | Incidence of culture proven sepsis | Day 7 |
| Incidence of rectal or gastrointestinal injury | 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. | Day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to achieve full enteral feeds | Enteral feeds (enteral nutrition or tube feeding) times | Day 14 |
| Duration of parenteral nutrition | Parenteral nutrition (PN) is a method of delivering essential nutrients directly into the bloodstream through an intravenous (IV) catheter. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Monica C Gierbolini Collazo, MD | Contact | 787-239-6289 | monica.gierbolinicollazo@advocatehelth.org |
| Name | Affiliation | Role |
|---|---|---|
| Ricardo J Rodriquez, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D008895 | Milk, Human |
| ID | Term |
|---|---|
| D008892 | Milk |
| D001628 | Beverages |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
Not provided
Not provided
Preterm infants born at >23 0/7 and <28 0/7 weeks' gestational age
Not provided
Not provided
Not provided
Not provided
| Day 14 |
| Time to first stool following intervention | Time to first stool following intervention | Day 7 |
| Total length of hospital stay | Total length of hospital stay | Day 120 |
| Number of central line days | Number of central line days | Day 120 |
| D003611 |
| Dairy Products |
| D005502 | Food |
| D019602 | Food and Beverages |