Whole Body Cooling Using Phase Changing Material

NCT01138176 | Unknown Phase 1 DMC

• 1 other identifier: PCM09
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

A prospective randomized control trial to examine safety and effectiveness of whole body cooling to a rectal temperature of 33.5 C using phase changing material in neonatal encephalopathy. Effectiveness will be defined by examining the stability of rectal temperature during cooling. Monitoring of vital signs, infection screen, blood counts, coagulation screen, liver and renal function tests, cranial US and MR imaging will be performed on recruited infants to evaluate safety of cooling. EEG will be performed on day 4 and hearing evaluation at discharge. Neurodevelopmental evaluation will be performed at 1 year of age.

Conditions

Hypoxic Ischemic Encephalopathy

Keywords

Neonatal encephalopathy; Therapeutic hypothermia; Phase changing material; MR imaging

Outcome Measures

Primary Outcomes (1)

• Stability of cooling

  Percentage of time for which rectal temperature is maintained between 33 to 34 C during the 72 hours of therapeutic hypothermia

  72 hours

Secondary Outcomes (5)

• Brain tissue injury on MR imaging

  7 to 10 days

• Adverse neurodevelopment

  12 months

• Mortality

  4 weeks

• EEG abnormality

  4 days

• Sepsis

  1 week

Study Arms (2)

Standard care

NO INTERVENTION

Procedure: Cooling

Cooling

EXPERIMENTAL

Reduction of rectal temperature to 33.5 C for 72 hours

Procedure: Cooling

Interventions

Cooling PROCEDURE

Reduction of rectal temperature to 33.5 C

Also known as: Therapeutic hypothermia, Whole body cooling

Cooling; Standard care

Eligibility Criteria

• Age: Up to 24 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Apgar score of \<5 at 5 minutes or continued resuscitation at 5 minutes
• Neonatal encephalopathy

You may not qualify if:

• Imminent death
• Major congenital malformations
• Gestation \<36 weeks
• Birthweight less than 1.8 kg

Sponsors & Collaborators

• Robertson, Nicola, M.D.: lead
• Thayyil, Sudhin: collaborator

Study Sites (1)

Calicut Medical College

Calicut, India

Location

Related Links

• UCL Institute for Women's Health

MeSH Terms

Conditions

Hypoxia-Ischemia, Brain

Interventions

Cool-Down Exercise; Hypothermia, Induced

Condition Hierarchy (Ancestors)

Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypoxia, Brain; Vascular Diseases; Cardiovascular Diseases; Hypoxia; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Post-Exercise Recovery Techniques; Physical Therapy Modalities; Therapeutics; Rehabilitation; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Cryotherapy

Study Officials

• Balraj Guhan, MD

  Calicut Medical College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDIV

Study Record Dates

• First Submitted: June 2, 2010
• First Posted: June 7, 2010
• Study Start: July 1, 2009
• Primary Completion: January 1, 2011
• Study Completion: August 1, 2011
• Last Updated: June 7, 2010

Record last verified: 2010-06

Locations

IN (1)