Necrotizing EnterocolitisCoolNECNCT01330576
Therapeutic Controlled Hypothermia in the Treatment of Neonates With Severe Necrotizing Enterocolitis
A study testing cooling blanket/mattress and Standard treatment of care at normothermia in people with Necrotizing Enterocolitis, run by Great Ormond Street Hospital for Children NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Hypothesis: Controlled hypothermia to 33.5C for 48 hours reduces the severity of critical illness in neonates with severe necrotizing enterocolitis. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Necrotizing Enterocolitis
- What is being tested?
- cooling blanket/mattress and Standard treatment of care at normothermia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 2 Aug 2010to 25 Mar 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Great Ormond Street Hospital for Children NHS Trust
London, WC1N 1EH
About this study
Hypothesis: Controlled hypothermia to 33.5C for 48 hours reduces the severity of critical illness in neonates with severe necrotizing enterocolitis.
- Conditions
- Necrotizing Enterocolitis
- Being tested
- cooling blanket/mattress, Standard treatment of care at normothermia
- Keywords
- Hypothermia, cooling, necrotizing enterocolitis, NEC, neonates, preterm
- Medical subject headings
- Enterocolitis, Necrotizing, Hypothermia, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cooling blanket/mattressProcedure or surgery
Therapeutic controlled hypothermia (33.5C) using cooling blanket/mattress
Standard treatment of care at normothermiaProcedure or surgery
Standard treatment of care in 33.5C for 48 hours
| Study group | Role | What they receive |
|---|---|---|
| Standard treatment of care at normothermia | Placebo comparator | Control group: Standard treatment of care at normothermia Receives: Procedure: Standard treatment of care at normothermia |
| cooling blanket/mattress | Experimental | Therapeutic controlled hypothermia (33.5C) using cooling blanket/mattress Receives: Procedure: cooling blanket/mattress |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in sequential organ failure assessment (SOFA) score
Difference in sequential organ failure assessment (SOFA) score at 5 days after intervention
Measured: 5 days
Secondary outcomes (2)
Baseline time taken to establish full enteral feeds
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
Measured: 5 days
Neurodevelopmental Assessment
Neurodevelopmental outcome with MRI at term corrected age and neurodevelopmental assessment at 3, 6,12 and 24 months and mortality data
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2011 (estimated)
- Study start2 Aug 2010
- Primary completion25 Mar 2013
- Study completion25 Mar 2013
Why it stopped: End of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Necrotizing EnterocolitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Great Ormond Street Hospital for Children NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01330576
- Sponsor's protocol ID
- 06SG14
- Acronym
- CoolNEC
- Status last verified
- Jan 2022
- First submitted
- 4 Apr 2011
- Last updated
- 3 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Hall NJ, Eaton S, Peters MJ, Hiorns MP, Alexander N, Azzopardi DV, Pierro A. Mild controlled hypothermia in preterm neonates with advanced necrotizing enterocolitis. Pediatrics. 2010 Feb;125(2):e300-8. doi: 10.1542/peds.2008-3211. Epub 2010 Jan 25.
PubMed 20100756
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Controlled Hypothermia in the Treatment of Neonates With Severe Necrotizing Enterocolitis
- ClinicalTrials.gov ID
- NCT01330576
- Acronym / sponsor ID
- CoolNEC / 06SG14
- Conditions
- Necrotizing Enterocolitis
- Keywords
- Hypothermia, cooling, necrotizing enterocolitis, NEC, neonates, preterm
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: End of funding
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Great Ormond Street Hospital for Children NHS Foundation TrustUniversity, hospital or other
- Study start
- 2 Aug 2010 (actual)
- Primary completion
- 25 Mar 2013 (actual)
- Study completion
- 25 Mar 2013 (actual)
- First posted
- 7 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hypothesis: Controlled hypothermia to 33.5C for 48 hours reduces the severity of critical illness in neonates with severe necrotizing enterocolitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard treatment of care at normothermia | Placebo comparator | Procedure: Standard treatment of care at normothermiaControl group: Standard treatment of care at normothermia |
| cooling blanket/mattress | Experimental | Procedure: cooling blanket/mattressTherapeutic controlled hypothermia (33.5C) using cooling blanket/mattress |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cooling blanket/mattressTherapeutic controlled hypothermia (33.5C) using cooling blanket/mattress | Procedure or surgery | cooling blanket/mattress |
| Standard treatment of care at normothermiaStandard treatment of care in 33.5C for 48 hours | Procedure or surgery | Standard treatment of care at normothermia |
Primary outcome
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
2 secondary outcomes
Baseline time taken to establish full enteral feeds
Time frame: 5 days
Neurodevelopmental Assessment
Time frame: 24 months
Results and safety
The study was stopped early (reason given: End of funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2022.
- Background: PubMed 20100756Hall NJ, Eaton S, Peters MJ, Hiorns MP, Alexander N, Azzopardi DV, Pierro A. Mild controlled hypothermia in preterm neonates with advanced necrotizing enterocolitis. Pediatrics. 2010 Feb;125(2):e300-8. doi: 10.1542/peds.2008-3211. Epub 2010 Jan 25.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cooling blanket/mattress and Standard treatment of care at normothermia in people with Necrotizing Enterocolitis, run by Great Ormond Street Hospital for Children NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: End of funding). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in sequential organ failure assessment (SOFA) score (time frame: 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01330576, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2022.