Whole Body Cooling Using Phase Changing Material

NCT ID: NCT01138176

Last Updated: 2010-06-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-07-31
• Study Completion Date: 2011-08-31

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.

Detailed Description

Meta-analyses of these trials show that therapeutic hypothermia increases survival with normal neurological function (pooled risk ratio of 1.53) with a number needed to treat of 8 (95% confidence interval (CI) 5 - 17) and in survivors reduces the rates of severe disability and cerebral palsy. Therapeutic hypothermia is now widely offered to moderately or severely asphyxiated infants in high-income countries.

The global burden of disease estimates indicate that perinatal asphyxia is a very significant problem in low and mid resourced settings. There are, however, several compelling reasons why the efficacy and safety data on therapeutic hypothermia from high-income countries cannot be extrapolated to neonatal units in transitional countries, such as India; in particular there is a lack of effective low tech servo controlled cooling equipments that can be used in these settings. This pilot phase II randomized control trial will examine the efficacy of phase changing material in providing satisfactory therapeutic hypothermia in neonatal encephalopathy, in a mid resource setting.

Conditions

Hypoxic Ischemic Encephalopathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Standard care

Group Type: NO_INTERVENTION

Cooling

Intervention Type: PROCEDURE

Reduction of rectal temperature to 33.5 C

Cooling

Reduction of rectal temperature to 33.5 C for 72 hours

Group Type: EXPERIMENTAL

Cooling

Intervention Type: PROCEDURE

Reduction of rectal temperature to 33.5 C

Interventions

Cooling

Reduction of rectal temperature to 33.5 C

Intervention Type: PROCEDURE

Other Intervention Names

Therapeutic hypothermia; Whole body cooling

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Maximum Eligible Age: 24 Hours
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Thayyil, Sudhin

INDIV

Sponsor Role: collaborator

Robertson, Nicola, M.D.

INDIV

Sponsor Role: lead

Responsible Party

Reader in Translational Neonatal Medicine

Principal Investigators

Balraj Guhan, MD

Role: PRINCIPAL_INVESTIGATOR

Calicut Medical College

Locations

Calicut Medical College

Calicut, , India

Countries

India

Related Links

http://www.instituteforwomenshealth.ucl.ac.uk/academic_research/neonatology

UCL Institute for Women's Health

Other Identifiers

PCM09

Identifier Type: -

Identifier Source: org_study_id