Infloran® for Prevention of Necrotizing Enterocolitis

NCT01751477 | Completed

• 1 other identifier: MUV-Neo3
• Study Type: observational
• Target: 463
• Locations: 1 country
• Sites: 2

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.

Conditions

Necrotizing Enterocolitis

Keywords

Very Low Birth Weight Infants; Probiotics; Necrotizing Enterocolitis

Outcome Measures

Primary Outcomes (1)

• Incidence of NEC

  NEC stages 2 or 3 according to Bell´s modified staging of NEC

  From birth to 37 weeks of gestational age (usually around 12 weeks)

Secondary Outcomes (2)

• Severity of NEC

  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®

  From birth to 37 weeks of gestational age (usually around 12 weeks)

Study Arms (2)

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 Criteria

• Age: Up to 7 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Medical University of Vienna: lead
• Wilheminenspital der Stadt Wien: collaborator

Study Sites (2)

Medical University Vienna

Vienna, 1090, Austria

Location

Wilheminenspital der Stadt Wien

Vienna, 1160, Austria

Location

Related Publications (1)

• Repa A, Thanhaeuser M, Endress D, Weber M, Kreissl A, Binder C, Berger A, Haiden N. Probiotics (Lactobacillus acidophilus and Bifidobacterium infantis) prevent NEC in VLBW infants fed breast milk but not formula [corrected]. Pediatr Res. 2015 Feb;77(2):381-8. doi: 10.1038/pr.2014.192. Epub 2014 Nov 25.

  PMID: 25423074 RESULT

Related Links

• Homepage Medical University Vienna

MeSH Terms

Conditions

Enterocolitis, Necrotizing

Condition Hierarchy (Ancestors)

Enterocolitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Andreas Repa, MD

  Medical University Vienna

  PRINCIPAL INVESTIGATOR

• Nadja Haiden, MD

  Medical University Vienna

  STUDY DIRECTOR

• Margarita Thanhäuser, MD

  Medical University Vienna

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 14, 2012
• First Posted: December 18, 2012
• Study Start: September 1, 2010
• Primary Completion: September 1, 2012
• Study Completion: October 1, 2012
• Last Updated: April 22, 2015

Record last verified: 2015-04

Locations

AU (2)