Early Diagnosis of Necrotising EnteroColitis: a prospective observational multicentre trial in neonates presenting with acute abdomen
| ISRCTN | ISRCTN14384676 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14384676 |
| Secondary identifying numbers | 1 |
- Submission date
- 15/04/2007
- Registration date
- 02/07/2007
- Last edited
- 11/05/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Ulf Kessler
Scientific
Scientific
Inselspital
Berne
CH-3010
Switzerland
| ulf.kessler@insel.ch |
Study information
| Study design | Prospective observational multicentre trial |
|---|---|
| Primary study design | Observational |
| Secondary study design | Multi-centre |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Parent information will be available at http://www.ednec.ch/ as soon as ethical approval is obtained |
| Scientific title | |
| Study acronym | ED-NEC |
| Study objectives | 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(s) | Ethics approval pending as of 11/05/2009 |
| Health condition(s) or problem(s) studied | Neonatal intestinal disease |
| Intervention | Assessment of an acute abdomen possibly due to NEC. |
| Intervention type | Other |
| Primary outcome measure | 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 study start date | 01/02/2010 |
| Completion date | 31/01/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | Both |
| Target number of participants | Added as of 11/05/2009: 50 infants diagnosed with NEC (previously 100) |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/02/2010 |
| Date of final enrolment | 31/01/2012 |
Locations
Countries of recruitment
- Austria
- Finland
- France
- Germany
- Netherlands
- Poland
- Sweden
- Switzerland
- United Kingdom
Study participating centre
Inselspital
Berne
CH-3010
Switzerland
CH-3010
Switzerland
Sponsor information
Island Hospital (Inselspital) (Switzerland)
Hospital/treatment centre
Hospital/treatment centre
-
Berne
CH-3010
Switzerland
| ednec@insel.ch | |
| Website | http://www.insel.ch/ |
"ROR" |
https://ror.org/01q9sj412 |
Funders
Funder type
University/education
Current information as of 11/05/2009:
No information available
University of Berne (Switzerland) - further applications in process
No information available
Initial information at time of registration:
No information available
Seventh Framework Programme (FP7) European Union Research Funding (Belgium) - In frame for this kind of funding
No information available
Further national and international programs, such as:
No information available
1. University of Berne (Switzerland)
No information available
2. Department of Surgical Paediatrics, Hospital of Berne (Switzerland)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | retrospective collection results: | 01/12/2006 | Yes | No | |
| Results article | case-control results: | 01/11/2008 | Yes | No |
