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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.
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:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | Placebo Comparator | Dietary Supplement: Placebo 2 cc/day of placebo diluted in mother's milk (when available) or premature formula. |
|
| Treatment Group | Active Comparator | Dietary Supplement: Heat Inactivated Probiotics 1 tsp heat inactivated Biotikid powder will be diluted in 2 cc of mother's milk (when available) or premature formula. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Heat Inactivated probiotics | Dietary Supplement | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Necrotizing Enterocolitis, Bell Stage 2 or above, or Death | Necrotizing Enterocolitis diagnosis will be based on clinical and radiographic criteria | Birth until 40 weeks post-conceptional age |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cathy Hammerman, MD | Contact | 0508685238 | cathyh@ekmd.huji.ac.il | |
| Alona Bin-Nun, MD | Contact | 0508685757 | alona.binnun@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Cathy Hammerman, MD | Shaare Zedek Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neonatal Intensive Care Unit - Shaare Zedek Medical Center | Jerusalem | 91031 | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20506712 | Background | Awad H, Mokhtar H, Imam SS, Gad GI, Hafez H, Aboushady N. Comparison between killed and living probiotic usage versus placebo for the prevention of necrotizing enterocolitis and sepsis in neonates. Pak J Biol Sci. 2010 Mar 15;13(6):253-62. doi: 10.3923/pjbs.2010.253.262. |
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| ID | Term |
|---|---|
| D020345 | Enterocolitis, Necrotizing |
| ID | Term |
|---|---|
| D004760 | Enterocolitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| Placebo | Dietary Supplement | 2 cc of milk will be given to control group |
|
| 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 |
| D007410 |
| Intestinal Diseases |