Enterocolitis, Necrotizing, Necrotizing Enterocolitis
Conditions
Brief summary
Prophylactic probiotics have been shown to decrease the incidence of Necrotizing Enterocolitis (NEC) in premature neonates. However, there is some resistance to giving live bacteria to small babies. Based on animal data, the investigators hypothesized that heat inactivated probiotics would also reduce NEC.
Detailed description
Preterm neonates, \<1500 gm birth weight will potentially be candidates for study and will be recruited when they begin enteral feeding. The infants will be prospectively and randomly assigned to one of two groups: 1. Treatment group - to receive daily inactivated probiotic prophylaxis starting with the initiation of feeds. 1 tsp powder will be diluted in 2 cc of mother's milk when possible or in Similac Special Care formula 24 cal when mother's milk is not available; and 2. Control group - to receive 2 cc/day of placebo similarly diluted. Supplements will be continued until the infant tolerates enteral feeds of 100 cc/kg/day or reaches 35 weeks post conceptual age (whichever comes LAST). Biotikid, a probiotic mixture, will be heated to 100 degrees C for 10 minutes. Babies will be followed clinically for signs of NEC, and with urine intestinal fatty acid binding protein (IFABP) and fecal calprotectin levels. The investigators primary aim is to demonstrate that premature neonates who are treated prophylactically with heat inactivated probiotics will have less necrotizing enterocolitis when compared to age matched infants given placebo. The investigators secondary objectives are to demonstrate the following: * That the decrease in NEC will coincide with improved intestinal barrier integrity, as reflected by levels of: * I-FABP in urine * Fecal Calprotectin
Interventions
DIETARY_SUPPLEMENTHeat Inactivated probiotics
Biotikid, a probiotic mixture, will be heated to 100 degrees Centigrade for 10 minutes to inactivate and then 1 tsp will be diluted in milk and give with feeds to treatment group
DIETARY_SUPPLEMENTPlacebo
2 cc of milk will be given to control group
Sponsors
Shaare Zedek Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Hours to 7 Days
Healthy volunteers
No
Inclusion criteria
* Preterm neonates * ≤1500 gm birth weight
Exclusion criteria
* Infants who are not deemed likely to survive more than one week; * Infants who are not started on enteral feeds by one week of age; * Infants who have significant congenital malformations or other gastrointestinal problem
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Necrotizing Enterocolitis, Bell Stage 2 or above, or Death | Birth until 40 weeks post-conceptional age | Necrotizing Enterocolitis diagnosis will be based on clinical and radiographic criteria |
Secondary
| Measure | Time frame |
|---|---|
| Increased Urine IFABP Levels | Weekly, from date of randomization until full enteral feeds (100 cc/kg/day) achieved or until death or necrotizing enterocolitis is diagnosed, whichever comes first until 37 weeks postconceptional age |
| Increased Fecal Calprotectin Levels | Weekly, from date of randomization until full enteral feeds (100 cc/kg/day) achieved or until death or necrotizing enterocolitis is diagnosed, whichever comes first until 37 weeks postconceptional age |
Countries
Israel
Contacts
Primary ContactCathy Hammerman, MD
Backup ContactAlona Bin-Nun, MD
Outcome results
None listed