Necrotizing EnterocolitisNCT01751477
Infloran® for Prevention of Necrotizing Enterocolitis
An observational study of Necrotizing Enterocolitis, run by Medical University of Vienna at 2 sites in Austria.
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. Read more about this study
- Who is it for?
- Ages Up to 7 days
- Conditions the study is for
- Necrotizing Enterocolitis
- Type of treatment
- Pill or oral medicine
- How many people
- 463 participants
- Where
- 2 sitesAustria
- Study dates
- Sep 2010to Oct 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 7 days
- All sexes
- No healthy volunteers
- Child
Study population: Very low birth weight Infants (<1500g birth weight)
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country.
Austria2 sites
Medical University Vienna
Vienna, 1090
Wilheminenspital der Stadt Wien
Vienna, 1160
About this study
Official title: Oral Probiotics (Infloran®) for Prevention of Necrotizing Enterocolitis in Very Low Birth Weight Infants
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.
Read more
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
- Medical subject headings
- Enterocolitis, Necrotizing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of NEC
NEC stages 2 or 3 according to Bell´s modified staging of NEC
Measured: From birth to 37 weeks of gestational age (usually around 12 weeks)
Secondary outcomes (2)
Severity of NEC
Measured: 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®
Measured: From birth to 37 weeks of gestational age (usually around 12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2012 (estimated)
- Study startSep 2010
- Primary completionSep 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Necrotizing EnterocolitisStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 463 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Collaborators
- Wilheminenspital der Stadt Wien
- Responsible party
- Principal investigator, Andreas Repa, Medical University of Vienna
- Investigators
- Andreas Repa, MD, Principal investigator, Medical University of ViennaNadja Haiden, MD, Study director, Medical University of ViennaMargarita Thanhäuser, MD, Study chair, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01751477
- Sponsor's protocol ID
- MUV-Neo3
- Status last verified
- Apr 2015
- First submitted
- 14 Dec 2012
- Last updated
- 22 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25423074
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Probiotics (Infloran®) for Prevention of Necrotizing Enterocolitis in Very Low Birth Weight Infants
- ClinicalTrials.gov ID
- NCT01751477
- Acronym / sponsor ID
- MUV-Neo3
- Conditions
- Necrotizing Enterocolitis
- Keywords
- Very Low Birth Weight Infants, Probiotics, Necrotizing Enterocolitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 463 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Collaborators
- Wilheminenspital der Stadt Wien
- Study start
- Sep 2010
- Primary completion
- Sep 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 18 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- Up to 7 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Very low birth weight Infants (<1500g birth weight)
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2015.
- Results publication: PubMed 25423074Repa 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.
- Homepage Medical University ViennaLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andreas Repa, MD principal investigator
Medical University of Vienna
Nadja Haiden, MD study director
Medical University of Vienna
Margarita Thanhäuser, MD study chair
Medical University of Vienna
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Necrotizing Enterocolitis, run by Medical University of Vienna at 2 sites in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of NEC (time frame: From birth to 37 weeks of gestational age (usually around 12 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01751477, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2015.