Condition category
Digestive System
Date applied
15/04/2007
Date assigned
02/07/2007
Last edited
11/05/2009
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.ednec.ch

Contact information

Type

Scientific

Primary contact

Dr Ulf Kessler

ORCID ID

Contact details

Inselspital
Berne
CH-3010
Switzerland
ulf.kessler@insel.ch

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

1

Study information

Scientific title

Acronym

ED-NEC

Study hypothesis

As of 11/05/2009 this record was significantly updated due to a change in the sources of funding and subsequent changes to the protocol. All updates can be found under the relevant fields with the above update date. At this time, the dates of the trial were also updated; the initial trial dates were as follows:
Initial anticipated start date: 01/01/2008
Initial anticipated end date: 31/12/2010

Current hypothesis as of 11/05/2009:
To establish biomarkers for necrotising enterocolitis (NEC) among neonates presenting with an acute abdomen.

Initial information at time of registration:
To test the capacity of the routine laboratory parameters C-reactive protein (CRP), differential blood count and blood gas analysis as well as additional novel parameters (fatty acid binding protein, platelet activating factor, markers of innate immunity, coagulation profile) in the early diagnosis of necrotising enterocolitis (NEC) among neonates presenting with an acute abdomen.

Ethics approval

Ethics approval pending as of 11/05/2009

Study design

Prospective observational multicentre trial

Primary study design

Observational

Secondary study design

Multi-centre

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Parent information will be available at http://www.ednec.ch/ as soon as ethical approval is obtained

Condition

Neonatal intestinal disease

Intervention

Assessment of an acute abdomen possibly due to NEC.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Current information as of 11/05/2009:
Differences of biomarkers between infants with NEC stage II and III and other diseases causing acute abdomen.

Initial information at time of registration:
Outcomes:
Evaluation of the clinical usefulness of promising laboratory parameters for early recognition of NEC among infants with acute gastrointestinal illness.

Endpoints - difference between diagnostic markers between groups:
1. For period one: at the end of period two, when all parameters are measured and statistically analysed (December 2009)
2. For period three: one year following the end of period three (December 2011)

Secondary outcome measures

Current information as of 11/05/2009:
1. Correlations between biomarkers and NEC disease severity (mortality, NEC stage, need for inotropic agents, mechanical ventilation, need for surgery)
2. Length of hospital stay

Initial information at time of registration:
Outcomes:
Prospective validation of statistically useful parameters from the first period by subdividing centres into application and non-application of a defined diagnostic algorithm.

Endpoints - prediction of mortality at a given time in either group:
1. Need for additional support with inotropic agents in either group. Will only be assessable during period three: one year following the end of period three (December 2011)
2. Prediction of the maximum disease severity as classified by Bell:
2.1. For period one: At the end of period two, when all parameters are measured and statistically analysed (December 2009)
2.2. For period three: one year following the end of period three (December 2011)

Overall trial start date

01/02/2010

Overall trial end date

31/01/2012

Reason abandoned

Eligibility

Participant inclusion criteria

Current information as of 11/05/2009:
1. Newborns below 36 days of postnatal age
2. Acute abdomen with suspicion of NEC
3. Gestational age below 34 weeks of gestational age (GA)
4. Written parental consent

Initial information at time of registration:
1. Newborns below 36 days of postnatal age
2. Clinical, laboratory and radiological assessment for an acute abdomen possibly due to NEC
3. For the diagnosis of NEC among infants presenting with an acute abdomen, the criteria of Bell, modified by Walsh and Kliegman and adopted by the Vermont Oxford Network:
3.1. The presence of one or more of the following clinical signs:
3.1.1. Feeding intolerance with bilious gastric aspirate or emesis
3.1.2. Abdominal distension
3.1.3. Occult or gross blood in stool (no fissure)
3.2. And one or more of the three following radiographic findings:
3.2.1. Pneumatosis intestinalis
3.2.2. Hepato-biliary gas
3.2.3. Pneumoperitoneum

Participant type

Patient

Age group

Neonate

Gender

Both

Target number of participants

Added as of 11/05/2009: 50 infants diagnosed with NEC (previously 100)

Participant exclusion criteria

Current information as of 11/05/2009:
1. Age above 35 days of postnatal age
2. Patients that had undergone surgery one week prior to onset of the disease

Initial information at time of registration:
1. Age above 35 days of postnatal age
2. Patients that had undergone surgery one week prior to onset of the disease
3. Focal intestinal perforation consistent with:
3.1. Visual aspect of the bowel at the time of surgery and post-mortem
3.2. Absence of inflammation and coagulative necrosis in histological findings

Recruitment start date

01/02/2010

Recruitment end date

31/01/2012

Locations

Countries of recruitment

Austria, Finland, France, Germany, Netherlands, Poland, Sweden, Switzerland, United Kingdom

Trial participating centre

Inselspital
Berne
CH-3010
Switzerland

Sponsor information

Organisation

Island Hospital (Inselspital) (Switzerland)

Sponsor details

-
Berne
CH-3010
Switzerland
ednec@insel.ch

Sponsor type

Hospital/treatment centre

Website

http://www.insel.ch/

Funders

Funder type

University/education

Funder name

Current information as of 11/05/2009:

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

University of Berne (Switzerland) - further applications in process

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Initial information at time of registration:

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Seventh Framework Programme (FP7) European Union Research Funding (Belgium) - In frame for this kind of funding

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Further national and international programs, such as:

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

1. University of Berne (Switzerland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

2. Department of Surgical Paediatrics, Hospital of Berne (Switzerland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2006 retrospective collection results: http://www.ncbi.nlm.nih.gov/pubmed/17122786
2. 2008 case-control results: http://www.ncbi.nlm.nih.gov/pubmed/18596574

Publication citations

  1. Kessler U, Mungnirandr A, Nelle M, Nimmo AF, Zachariou Z, Berger S, A simple presurgical necrotizing enterocolitis-mortality scoring system., J Perinatol, 2006, 26, 12, 764-768, doi: 10.1038/sj.jp.7211613.

  2. Schlapbach LJ, Aebi C, Fisch U, Ammann RA, Otth M, Bigler S, Nelle M, Berger S, Kessler U, Higher cord blood levels of mannose-binding lectin-associated serine protease-2 in infants with necrotising enterocolitis., Pediatr. Res., 2008, 64, 5, 562-566, doi: 10.1203/PDR.0b013e3181841335.

Additional files

Editorial Notes