Infloran® for Prevention of Necrotizing Enterocolitis

Necrotizing Enterocolitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01751477
• Other study ID #: MUV-Neo3
• Status: Completed
• Phase: N/A
• First received: December 14, 2012
• Last updated: April 20, 2015
• Start date: September 2010
• Est. completion date: October 2012

Study information

• Verified date: April 2015
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Ethikkommission
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 463
• Est. completion date: October 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 7 Days

Eligibility

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)

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Enterocolitis
• Enterocolitis, Necrotizing
• Necrotizing Enterocolitis

Locations

Country	Name	City	State
Austria	Medical University Vienna	Vienna
Austria	Wilheminenspital der Stadt Wien	Vienna

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of Vienna	Wilheminenspital der Stadt Wien

Country where clinical trial is conducted

Austria, 

References & Publications (1)

Repa A, Thanhaeuser M, Endress D, Weber M, Kreissl A, Binder C, Berger A, Haiden N. Probiotics (Lactobacillus acidophilus and Bifidobacterium bifidum) prevent NEC in VLBW infants fed breast milk but not formula. Pediatr Res. 2015 Feb;77(2):381-8. doi: 10. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	Severity of NEC		From birth to 37 weeks of gestational age (usually around 12 weeks)	No
Secondary	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)	No

External Links

•   Homepage Medical University Vienna