Infloran® for Prevention of Necrotizing Enterocolitis

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.

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Key information

Conditions

Necrotizing Enterocolitis Digestive System Diseases Enterocolitis Enterocolitis, Necrotizing Gastroenteritis Gastrointestinal Diseases Intestinal Diseases

Age range

Up to 7 day

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical University Vienna, Vienna, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

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

Secondary outcomes

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)

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Collaborators

Wilheminenspital der Stadt Wien

Registry information

Official study title

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

Important dates

Study start: 2010
Primary completion: 2012
Study completion: 2012
First posted: Dec 18, 2012
Registry last updated: Apr 22, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed