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Infloran® for Prevention of Necrotizing Enterocolitis

NCT01751477 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 463

Last updated 2015-04-22

No results posted yet for this study

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

Sponsors & Collaborators

  • Wilheminenspital der Stadt Wien

    collaborator UNKNOWN

  • Medical University of Vienna

    lead OTHER

Principal Investigators

  • Andreas Repa, MD · Medical University Vienna

  • Nadja Haiden, MD · Medical University Vienna

  • Margarita Thanhäuser, MD · Medical University Vienna

Eligibility

Max Age
7 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2012-09-30
Completion
2012-10-31

Countries

  • Austria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01751477 on ClinicalTrials.gov