Infloran® for Prevention of Necrotizing Enterocolitis

This study has been completed.
Sponsor:
Collaborator:
Wilheminenspital der Stadt Wien
Information provided by (Responsible Party):
Andreas Repa, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01751477
First received: December 14, 2012
Last updated: April 24, 2013
Last verified: April 2013
  Purpose

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
Necrotizing Enterocolitis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Oral Probiotics (Infloran®) for Prevention of Necrotizing Enterocolitis in Very Low Birth Weight Infants

Resource links provided by NLM:


Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • Incidence of NEC [ Time Frame: From birth to 37 weeks of gestational age (usually around 12 weeks) ] [ Designated as safety issue: No ]
    NEC stages 2 or 3 according to Bell´s modified staging of NEC


Secondary Outcome Measures:
  • Severity of NEC [ Time Frame: From birth to 37 weeks of gestational age (usually around 12 weeks) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]

Enrollment: 450
Study Start Date: September 2010
Study Completion Date: October 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Probiotics (Infloran)
Very low birth weight Infants receiving 2 capsules/d Infloran starting in the first week of life
Control
Very low birth weight Infants who did not receive Infloran (historical cohort)

  Eligibility

Ages Eligible for Study:   up to 7 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Very low birth weight Infants (<1500g birth weight)

Criteria

Inclusion Criteria:

  • Neonates admitted to the neonatal intensive care unit on day 1 of life
  • Very low birth weight (<1500 gram)
  • Prematurity < 34/0 weeks gestational age
  • For group receiving probiotics: 230 infants born after the 20/Sep/2010 (i.e. date of introduction of Infloran in clinical routine)
  • For control group (historical): 230 infants born before 2010

Exclusion Criteria:

  • Malformation of the gut (omphalocele, gastroschisis, intestinal atresia)
  • Death before seven days of life, except due to NEC
  • Transfer to another hospital before 37 weeks of corrected gestational age, except those who were transferred to a partner clinic using the same protocol for probiotic supplementation
  • For group receiving probiotics: Infants who did not receive Infloran® starting in the first week of life or stopped before 34 weeks gestational age, except infants who developed NEC (reason for discontinuation of Infloran)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01751477

Locations
Austria
Medical University Vienna
Vienna, Austria, 1090
Wilheminenspital der Stadt Wien
Vienna, Austria, 1160
Sponsors and Collaborators
Medical University of Vienna
Wilheminenspital der Stadt Wien
Investigators
Principal Investigator: Andreas Repa, MD Medical University Vienna
Study Director: Nadja Haiden, MD Medical University Vienna
Study Chair: Margarita Thanhäuser, cand. med. Medical University Vienna
  More Information

Additional Information:
No publications provided

Responsible Party: Andreas Repa, MD, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01751477     History of Changes
Other Study ID Numbers: MUV-Neo3
Study First Received: December 14, 2012
Last Updated: April 24, 2013
Health Authority: Austria: Ethikkommission

Keywords provided by Medical University of Vienna:
Very Low Birth Weight Infants
Probiotics
Necrotizing Enterocolitis

Additional relevant MeSH terms:
Enterocolitis
Enterocolitis, Necrotizing
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on April 15, 2014