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

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

Sponsors

Lead Sponsor: Great Ormond Street Hospital for Children NHS Foundation Trust

Source Great Ormond Street Hospital for Children NHS Foundation Trust
Brief Summary

Hypothesis: Controlled hypothermia to 33.5C for 48 hours reduces the severity of critical illness in neonates with severe necrotizing enterocolitis.

Overall Status Unknown status
Start Date August 2010
Primary Completion Date August 2013
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Difference in sequential organ failure assessment (SOFA) score 5 days
Secondary Outcome
Measure Time Frame
Baseline time taken to establish full enteral feeds 5 days
Neurodevelopmental Assessment 24 months
Enrollment 46
Condition
Intervention

Intervention Type: Procedure

Intervention Name: cooling blanket/mattress

Description: Therapeutic controlled hypothermia (33.5C) using cooling blanket/mattress

Arm Group Label: cooling blanket/mattress

Intervention Type: Procedure

Intervention Name: Standard treatment of care at normothermia

Description: Standard treatment of care in 33.5C for 48 hours

Arm Group Label: Standard treatment of care at normothermia

Eligibility

Criteria:

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

Gender: All

Minimum Age: N/A

Maximum Age: N/A

Healthy Volunteers: No

Location
Facility: Status: Contact: Investigator: Great Ormond Street Hospital for Children NHS Trust Agostino Pierro, Professor [email protected] Nurain Sim, Dr Principal Investigator
Location Countries

United Kingdom

Verification Date

March 2012

Responsible Party

Name Title: Research Governance Co-ordinator

Organization: Great Ormond Street Hospital for Children NHS Trust

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Standard treatment of care at normothermia

Type: Placebo Comparator

Description: Control group: Standard treatment of care at normothermia

Label: cooling blanket/mattress

Type: Experimental

Description: Therapeutic controlled hypothermia (33.5C) using cooling blanket/mattress

Acronym CoolNEC
Study Design Info

Allocation: Randomized

Intervention Model: Single Group Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov