NCT01751477

Infloran® for Prevention of Necrotizing Enterocolitis

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 463 (actual)
• Sponsor: Medical University of Vienna · Academic / Other
• Sex: All
• Age: 7 Days
• Healthy volunteers: Not accepted

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.

Conditions

• Necrotizing Enterocolitis

Timeline

• Start date: 2010-09-01
• Primary completion: 2012-09-01
• Completion: 2012-10-01
• First posted: 2012-12-18
• Last updated: 2015-04-22

Locations

2 sites across 1 country: Austria