Infloran® for Prevention of Necrotizing Enterocolitis
|ClinicalTrials.gov Identifier: NCT01751477|
Recruitment Status : Completed
First Posted : December 18, 2012
Last Update Posted : April 22, 2015
Necrotizing enterocolitis (NEC) is one of the most devastating gastrointestinal emergencies in preterm neonates and a leading cause of death and morbidity.
The pathogenesis of NEC remains largely unclear, but it is widely considered as a multifactorial disease. Prematurity, enteral feeding, bacterial colonisation of the gut and intestinal ischemia have been proposed as major risk factors.
Probiotics may prevent NEC by improving the maturity and function of the gut mucosal barrier, modulating the immune system, promoting colonization of the gut with beneficial organisms and preventing colonization by pathogens.
A variety of clinical trials have evaluated the effect of different probiotic preparations on the occurrence of NEC in preterm infants. The results of recent metaanalyses suggest a benefit of probiotic bacteria in reducing the incidence of NEC and propose a change of practice.
The aim of the study is to evaluate the efficacy of the probiotic preparation Infloran® in reducing the incidence of NEC after implementation in clinical routine in preterm (< 34 weeks gestational age) very low birth weight infants compared to a historical cohort.
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||463 participants|
|Official Title:||Oral Probiotics (Infloran®) for Prevention of Necrotizing Enterocolitis in Very Low Birth Weight Infants|
|Study Start Date :||September 2010|
|Actual Primary Completion Date :||September 2012|
|Actual Study Completion Date :||October 2012|
Very low birth weight Infants receiving 2 capsules/d Infloran starting in the first week of life
Very low birth weight Infants who did not receive Infloran (historical cohort)
- Incidence of NEC [ Time Frame: From birth to 37 weeks of gestational age (usually around 12 weeks) ]NEC stages 2 or 3 according to Bell´s modified staging of NEC
- Severity of NEC [ Time Frame: From birth to 37 weeks of gestational age (usually around 12 weeks) ]
- Influence of enteral feeding with human milk or formula on the incidence of NEC after the implementation of Infloran® [ Time Frame: From birth to 37 weeks of gestational age (usually around 12 weeks) ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01751477
|Medical University Vienna|
|Vienna, Austria, 1090|
|Wilheminenspital der Stadt Wien|
|Vienna, Austria, 1160|
|Principal Investigator:||Andreas Repa, MD||Medical University Vienna|
|Study Director:||Nadja Haiden, MD||Medical University Vienna|
|Study Chair:||Margarita Thanhäuser, MD||Medical University Vienna|