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

NCT01330576 | Terminated

• 1 other identifier: 06SG14
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Necrotizing Enterocolitis

Keywords

Hypothermia; cooling; necrotizing enterocolitis; NEC; neonates; preterm

Outcome Measures

Primary Outcomes (1)

• Difference in sequential organ failure assessment (SOFA) score

  Difference in sequential organ failure assessment (SOFA) score at 5 days after intervention

  5 days

Secondary Outcomes (2)

• Baseline time taken to establish full enteral feeds

  5 days

• Neurodevelopmental Assessment

  24 months

Study Arms (2)

Standard treatment of care at normothermia

PLACEBO COMPARATOR

Control group: Standard treatment of care at normothermia

Procedure: Standard treatment of care at normothermia

cooling blanket/mattress

EXPERIMENTAL

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

Procedure: cooling blanket/mattress

Interventions

cooling blanket/mattress PROCEDURE

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

cooling blanket/mattress

Standard treatment of care at normothermia PROCEDURE

Standard treatment of care in 33.5C for 48 hours

Standard treatment of care at normothermia

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Great Ormond Street Hospital for Children NHS Foundation Trust: lead

Study Sites (1)

Great Ormond Street Hospital for Children NHS Trust

London, WC1N 1EH, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 20100756 BACKGROUND

MeSH Terms

Conditions

Enterocolitis, Necrotizing; Hypothermia; Premature Birth

Interventions

Beds

Condition Hierarchy (Ancestors)

Enterocolitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Equipment and Supplies, Hospital; Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2011
• First Posted: April 7, 2011
• Study Start: August 2, 2010
• Primary Completion: March 25, 2013
• Study Completion: March 25, 2013
• Last Updated: February 3, 2022

Record last verified: 2022-01

Locations

GB (1)