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STAT Trial

Welcome

Recruitment
Randomisation

STAT Trial Pack

STAT trial protocol
Inclusion/exclusion criteria
Parent information sheet
Consent form
Randomisation


Forms
Form A: Data Collection

Form B: Daily Data Collection

Form C: Patient Death

Form D1: One month follow up

Form D2: Six months follow up

Form D3: 1 Year follow up

Form E: Operation Details


Contact us
Collaborating centres

Welcome

Welcome to the STAT Trial website.

The STAT Trial is an international, multicentre, prospective randomised controlled trial comparing intestinal resection with stoma formation or intestinal resection with primary anastomosis in the surgical management of neonates with necrotizing enterocolitis (NEC).

About the STAT trial: Definition

STAT stands for: Stoma or Intestinal Anastomosis for Necrotizing Enterocolitis of the Neonate.

Aim

The trial is an international collaboration designed to answer the question:

Which is the most effective operation for neonates with necrotizing enterocolitis (NEC): intestinal resection with stoma formation or intestinal resection with primary anastomosis?

STAT is a prospective randomised controlled trial with currently 10 participating centres internationally (UK, USA, Canada, Italy, Netherlands, Sweden, Serbia and Latvia).

The lead centre is the Institute of Child Health and Great Ormond Street Hospital for Children, London, UK.

Recruitment

With parental consent, 80 neonates with suspected NEC or need for laparotomy based on radiological signs of intestinal perforation or failure of improvement with medical treatment will be randomised at laparotomy to either stoma formation or primary anastomosis. The neonates will be monitored for the recovery of intestinal function after surgery for NEC by duration of parenteral nutrition (days).

Several secondary outcome measures will also be compared between the two treatment groups. (See STAT trial protocol for full details)

Randomisation

To randomise a new patient into the STAT Trial you will need the following:

  1. STAT trial login name and password for your centre
  2. All patient information from: Form A: Randomisation
  3. The patient must meet all the inclusion criteria and none of the exclusion criteria
  4. RANDOMISE A NEW PATIENT NOW

STAT trial pack

Download PDFs of all forms required for the STAT trial:

Contact us

Email: stat.trial@ich.ucl.ac.uk
Telephone: +44 (0)20 7905 2682
Fax: +44 (0)20 7404 6161


Department of Paediatric Surgery
Institute of Child Health and Great Ormond Street Hospital for Children
30 Guilford Street
London  WC1N 1EH
United Kingdom

Collaborating centres

  • Great Ormond Street Hospital for Children & Institute of Child Health, London, UK
  • Chelsea & Westminster Hospital, London, UK
  • King’s College Hospital, London, UK
  • The Hospital for Sick Children, Canada
  • BC Children's Hospital, British Columbia, Canada
  • Alberta Children’s Hospital, Canada
  • Children's Hospital of Pittsburgh of UPMC
  • Sophia’s Children’s Hospital, Netherlands
  • University Children’s Hospital, Belgrade, Serbia
  • Astrid Lindgren Children's Hospital/Karolinska University Hospital, Sweeden
  • Children’s University Hospital, Riga, Latvia

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Page last modified on 03 sep 10 12:16