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ISRCTN
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ISRCTN18282954
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ClinicalTrials.gov identifier
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Public title
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NET (Necrotising Enterocolitis Trial) - primary peritoneal drainage in necrotising enterocolitis: randomised controlled multi-centre trial
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Scientific title
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Acronym
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NET
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Serial number at source
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MREC/02/2/34
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Study hypothesis
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To determine whether primary peritoneal drainage improves the survival and outcome of ELBW infants with perforated necrotising enterocolitis (NEC) or with isolated intestinal perforation.
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Ethics approval
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This project has been approved by an independent research ethics committee.
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Study design
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Randomised controlled trial
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Countries of recruitment
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Australia, Belgium, France, Hong Kong, Ireland, Italy, Japan, Korea, the Netherlands, New Zealand, South Africa, Spain, Switzerland, United Kingdom, United States of America
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Disease/condition/study domain
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Necrotising enterocolitis or isolated intestinal perforation
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Participants - inclusion criteria
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Extremely low birth weight (ELBW) infants (weight less than or equal to 1000g) with perforated necrotising enterocolitis or isolated perforation.
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Participants - exclusion criteria
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1. Bilateral grade 4 intraventricular haemorrhages
2. Previous laparotomy
3. Previous peritoneal drain
4. Recurrent NEC
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Anticipated start date
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01/11/2002
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Anticipated end date
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20/03/2006
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Status of trial
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Completed |
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Patient information material
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Parent information sheets are available in English (http://www.ich.ucl.ac.uk/ich/html/academicunits/surgery/nettrial/downloads/NET_ParentInfo.pdf) and in German (http://www.ich.ucl.ac.uk/ich/html/academicunits/surgery/nettrial/downloads/NET_ParentInfo_German.pdf).
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Target number of participants
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208
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Interventions
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Primary peritoneal drain or laparotomy.
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Primary outcome measure(s)
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Survival at 1 and 6 months after randomisation.
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Secondary outcome measure(s)
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1. Time to death (days)
2. Cause of death (related to abdominal sepsis/not related to abdomen [cardiac
anomaly/cerebral haemorrhage/other])
3. Hospital stay for survivors and non survivors (days)
4. Intestinal absorptive function. This will be assessed by measuring:
4.1. The calorie intake (kcal/kg/day) both enterally and parenterally 1 month and 6 months after randomisation
4.2. The weight gain at 1 month and 6 months after randomisation
4.3. The duration of parenteral nutrition (days)
4.4. The time to full enteral feeding (days)
5. Long term intestinal complications:
5.1. Intestinal stricture (confirmed by a contrast study and/or histology)
5.2. Persistent entero-cutaneous fistula
6. Intraventricular haemorrhage (ultrasound scan of the brain at enrolment in the trial and 2 weeks after randomisation); intraventricular haemorrhages will be graded (grade I to IV) according to their extent and severity
7. Respiratory function. This will be assessed by assessing the need for assisted ventilation or oxygen dependency at 1 and 6 months after randomisation.
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Sources of funding
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Stanley Thomas Johnson Foundation (Switzerland)
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Trial website
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http://www.nettrial.net/
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Publications
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Results in http://www.ncbi.nlm.nih.gov/pubmed/18580206
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Contact name
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Prof
Agostino
Pierro
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Address
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Dept of Surgery
Institute of Child Health
30 Guilford St
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City/town
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London
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Zip/Postcode
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WC1N 1EH
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Country
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United Kingdom
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Tel
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+44 (0)20 7905 2641
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Fax
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+44 (0)20 7404 6181
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Email
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a.pierro@ich.ucl.ac.uk
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Sponsor
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Institute of Child Health and Great Ormond Street Hospital (UK)
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Address
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30 Guilford St
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City/town
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London
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Zip/Postcode
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WC1N 1EH
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Country
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United Kingdom
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Tel
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+44 (0)20 7905 2641
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Fax
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+44 (0)20 7404 6181
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Email
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net@nettrial.net
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Date applied
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15/03/2004
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Last edited
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30/06/2008
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Date ISRCTN assigned
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13/04/2004
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