Therapeutic Controlled Hypothermia in the Treatment of Neonates With Severe Necrotizing Enterocolitis (CoolNEC)

January 20, 2022 updated by: Great Ormond Street Hospital for Children NHS Foundation Trust
Hypothesis: Controlled hypothermia to 33.5C for 48 hours reduces the severity of critical illness in neonates with severe necrotizing enterocolitis.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, WC1N 1EH
        • Great Ormond street Hospital for Children NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • weight at diagnosis > 700 grams
  • confirmed NEC (Bell's stage II or III)
  • radiological evidence of pneumatosis coli
  • systemic compromise as defined by increase in ventilation requirement and/or requiring inotopic support

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Standard treatment of care at normothermia
Control group: Standard treatment of care at normothermia
Procedure: Standard treatment of care at normothermia
Standard treatment of care in 33.5C for 48 hours
Experimental: cooling blanket/mattress
Therapeutic controlled hypothermia (33.5C) using cooling blanket/mattress
Procedure: cooling blanket/mattress
Therapeutic controlled hypothermia (33.5C) using cooling blanket/mattress

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in sequential organ failure assessment (SOFA) score
Time Frame: 5 days
Difference in sequential organ failure assessment (SOFA) score at 5 days after intervention
5 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Baseline time taken to establish full enteral feeds
Time Frame: 5 days
Time to establish full enteral feeds and organ functional investigation and biomarkers at baseline, 24 hours post, 63 hours post and day 5 post intervention
5 days
Neurodevelopmental Assessment
Time Frame: 24 months
Neurodevelopmental outcome with MRI at term corrected age and neurodevelopmental assessment at 3, 6,12 and 24 months and mortality data
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Great Ormond Street Hospital for Children NHS Foundation Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 2, 2010

Primary Completion (Actual)

March 25, 2013

Study Completion (Actual)

March 25, 2013

Study Registration Dates

First Submitted

April 4, 2011

First Submitted That Met QC Criteria

April 5, 2011

First Posted (Estimate)

April 7, 2011

Study Record Updates

Last Update Posted (Actual)

February 3, 2022

Last Update Submitted That Met QC Criteria

January 20, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 06SG14

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Necrotizing Enterocolitis

Clinical Trials on Standard treatment of care at normothermia

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kyrgyzstan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe