Early Diagnosis of Necrotising EnteroColitis: a prospective observational multicentre trial in neonates presenting with acute abdomen

• Register: ISRCTN
• Last refreshed on: 13 January 2015
• Main ID: ISRCTN14384676
• Date of registration: 02/07/2007
• Prospective Registration: Yes
• Primary sponsor: Island Hospital (Inselspital) (Switzerland)
• Public title: Early Diagnosis of Necrotising EnteroColitis: a prospective observational multicentre trial in neonates presenting with acute abdomen
• Date of first enrolment: 01/02/2010
• Target sample size: 50
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN14384676
• Study type: Observational
• Study design: Prospective observational multicentre trial (Diagnostic)

Countries of recruitment

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

Contacts

• Name: Ulf Kessler

Key inclusion & exclusion criteria

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
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

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Neonatal intestinal disease
Digestive System
Intestinal disease

Intervention(s)

Assessment of an acute abdomen possibly due to NEC.

Primary Outcome(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)

Secondary Outcome(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)

Source(s) of Monetary Support

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)