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
Protocol serial number	1
Sponsor	Island Hospital (Inselspital) (Switzerland)
Funders	Current information as of 11/05/2009:, University of Berne (Switzerland) - further applications in process, Initial information at time of registration:, Seventh Framework Programme (FP7) European Union Research Funding (Belgium) - In frame for this kind of funding, Further national and international programs, such as:, 1. University of Berne (Switzerland), 2. Department of Surgical Paediatrics, Hospital of Berne (Switzerland)

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

Inselspital
Berne
CH-3010
Switzerland

Email	ulf.kessler@insel.ch

Study information

Primary study design	Observational
Study design	Prospective observational multicentre trial
Secondary study design	Multi-centre
Study type	Participant information sheet
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(s)	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)
Key secondary outcome measure(s)	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)
Completion date	31/01/2012

Eligibility

Participant type(s)	Patient
Age group	Neonate
Sex	All
Target sample size at registration	50
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

United Kingdom
Austria
Finland
France
Germany
Netherlands
Poland
Sweden
Switzerland

Study participating centre

Inselspital

Berne
CH-3010
Switzerland

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Study website	Study website	11/11/2025	11/11/2025	No	Yes