Condition category
Digestive System
Date applied
15/03/2004
Date assigned
13/04/2004
Last edited
15/11/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.nettrial.net/

Contact information

Type

Scientific

Primary contact

Prof Agostino Pierro

ORCID ID

Contact details

Dept of Surgery
Institute of Child Health
30 Guilford St
London
WC1N 1EH
United Kingdom
+44 (0)20 7905 2641
a.pierro@ich.ucl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

MREC/02/2/34

Study information

Scientific title

Acronym

NET

Study hypothesis

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

This project has been approved by an independent research ethics committee.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient 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).

Condition

Necrotising enterocolitis or isolated intestinal perforation

Intervention

Primary peritoneal drain or laparotomy.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/11/2002

Overall trial end date

20/03/2006

Reason abandoned

Eligibility

Participant inclusion criteria

Extremely low birth weight (ELBW) infants (weight less than or equal to 1000g) with perforated necrotising enterocolitis or isolated perforation.

Participant type

Patient

Age group

Neonate

Gender

Both

Target number of participants

208

Participant exclusion criteria

1. Bilateral grade 4 intraventricular haemorrhages
2. Previous laparotomy
3. Previous peritoneal drain
4. Recurrent NEC

Recruitment start date

01/11/2002

Recruitment end date

20/03/2006

Locations

Countries of recruitment

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

Trial participating centre

Dept of Surgery
London
WC1N 1EH
United Kingdom

Sponsor information

Organisation

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

Sponsor details

30 Guilford St
London
WC1N 1EH
United Kingdom
+44 (0)20 7905 2641
net@nettrial.net

Sponsor type

Research organisation

Website

Funders

Funder type

Charity

Funder name

Stanley Thomas Johnson Foundation (Switzerland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Results in http://www.ncbi.nlm.nih.gov/pubmed/18580206

Publication citations

  1. Results

    Rees CM, Eaton S, Kiely EM, Wade AM, McHugh K, Pierro A, Peritoneal drainage or laparotomy for neonatal bowel perforation? A randomized controlled trial., Ann. Surg., 2008, 248, 1, 44-51, doi: 10.1097/SLA.0b013e318176bf81.

Additional files

Editorial Notes