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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01751477
Other study ID # MUV-Neo3
Secondary ID
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 InfloranĀ® 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


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 BellĀ“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
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