Clinical Trial: Infloran® for Prevention of Necrotizing Enterocolitis

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Oral Probiotics (Infloran®) for Prevention of Necrotizing Enterocolitis in Very Low Birth Weight Infants

Brief Summary:

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.


Detailed Summary:
Sponsor: Medical University of Vienna

Current Primary Outcome: 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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) ]


Original Secondary Outcome: Same as current

Information By: Medical University of Vienna

Dates:
Date Received: December 14, 2012
Date Started: September 2010
Date Completion:
Last Updated: April 20, 2015
Last Verified: April 2015