NET (Necrotising Enterocolitis Trial) - primary peritoneal drainage in necrotising enterocolitis: randomised controlled multi-centre trial

ISRCTN	ISRCTN18282954
DOI	https://doi.org/10.1186/ISRCTN18282954
Secondary identifying numbers	MREC/02/2/34

Submission date: 15/03/2004
Registration date: 13/04/2004
Last edited: 15/11/2013

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

Study website

Contact information

Prof Agostino Pierro
Scientific

Dept of Surgery
Institute of Child Health
30 Guilford St
London
WC1N 1EH
United Kingdom

Phone	+44 (0)20 7905 2641
Email	a.pierro@ich.ucl.ac.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	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).
Scientific title
Study acronym	NET
Study objectives	To determine whether primary peritoneal drainage improves the survival and outcome of ELBW infants with perforated necrotising enterocolitis (NEC) or with isolated intestinal perforation.
Ethics approval(s)	This project has been approved by an independent research ethics committee.
Health condition(s) or problem(s) studied	Necrotising enterocolitis or isolated intestinal perforation
Intervention	Primary peritoneal drain or laparotomy.
Intervention type	Other
Primary outcome measure	Survival at 1 and 6 months after randomisation.
Secondary outcome measures	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.
Overall study start date	01/11/2002
Completion date	20/03/2006

Eligibility

Participant type(s)	Patient
Age group	Neonate
Sex	Both
Target number of participants	208
Key inclusion criteria	Extremely low birth weight (ELBW) infants (weight less than or equal to 1000g) with perforated necrotising enterocolitis or isolated perforation.
Key exclusion criteria	1. Bilateral grade 4 intraventricular haemorrhages 2. Previous laparotomy 3. Previous peritoneal drain 4. Recurrent NEC
Date of first enrolment	01/11/2002
Date of final enrolment	20/03/2006

Locations

Countries of recruitment

Australia
Belgium
England
France
Hong Kong
Ireland
Italy
Japan
Korea, South
Netherlands
New Zealand
South Africa
Spain
Switzerland
United Kingdom
United States of America

Study participating centre

Dept of Surgery

London
WC1N 1EH
United Kingdom

Sponsor information

Institute of Child Health and Great Ormond Street Hospital (UK)
Research organisation

30 Guilford St
London
WC1N 1EH
United Kingdom

Phone	+44 (0)20 7905 2641
Email	net@nettrial.net
"ROR"	https://ror.org/00zn2c847

Funders

Funder type

Charity

Stanley Thomas Johnson Foundation (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	Results	01/07/2008		Yes	No