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Whole Body Cooling Using Phase Changing Material

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2010 by Robertson, Nicola, M.D..
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01138176
First Posted: June 7, 2010
Last Update Posted: June 7, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Thayyil, Sudhin
Information provided by:
Robertson, Nicola, M.D.
  Purpose
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.

Condition Intervention Phase
Hypoxic Ischemic Encephalopathy Procedure: Cooling Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase II Randomized Control Trial of Whole Body Cooling in Neonatal Encephalopathy Using Phase Changing Material

Further study details as provided by Robertson, Nicola, M.D.:

Primary Outcome Measures:
  • Stability of cooling [ Time Frame: 72 hours ]
    Percentage of time for which rectal temperature is maintained between 33 to 34 C during the 72 hours of therapeutic hypothermia


Secondary Outcome Measures:
  • Brain tissue injury on MR imaging [ Time Frame: 7 to 10 days ]
    Basal ganglia, white matter and cortical lesions scored from 0 to 3

  • Adverse neurodevelopment [ Time Frame: 12 months ]
    severe neurodevelopmental impairment (defined as scores of <60 on neurological examination30 and/or a developmental score < 2SD (DASII) below the mean and/or GMFCS>II), microcephaly (head circumference <2 SD below mean), severe visual or hearing impairment

  • Mortality [ Time Frame: 4 weeks ]
    Death until hospital discharge

  • EEG abnormality [ Time Frame: 4 days ]
    Abnormal background activity

  • Sepsis [ Time Frame: 1 week ]
    Blood or CSF culture positive sepsis


Estimated Enrollment: 35
Study Start Date: July 2009
Estimated Study Completion Date: August 2011
Estimated Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Standard care Procedure: Cooling
Reduction of rectal temperature to 33.5 C
Other Names:
  • Therapeutic hypothermia
  • Whole body cooling
Experimental: Cooling
Reduction of rectal temperature to 33.5 C for 72 hours
Procedure: Cooling
Reduction of rectal temperature to 33.5 C
Other Names:
  • Therapeutic hypothermia
  • Whole body cooling

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 24 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01138176


Locations
India
Calicut Medical College
Calicut, India
Sponsors and Collaborators
Robertson, Nicola, M.D.
Thayyil, Sudhin
Investigators
Principal Investigator: Balraj Guhan, MD Calicut Medical College
  More Information

Additional Information:
Responsible Party: Nicola Robertson, Reader in Translational Neonatal Medicine
ClinicalTrials.gov Identifier: NCT01138176     History of Changes
Other Study ID Numbers: PCM09
First Submitted: June 2, 2010
First Posted: June 7, 2010
Last Update Posted: June 7, 2010
Last Verified: June 2010

Keywords provided by Robertson, Nicola, M.D.:
Neonatal encephalopathy
Therapeutic hypothermia
Phase changing material
MR imaging

Additional relevant MeSH terms:
Brain Diseases
Brain Ischemia
Hypoxia-Ischemia, Brain
Central Nervous System Diseases
Nervous System Diseases
Cerebrovascular Disorders
Vascular Diseases
Cardiovascular Diseases
Hypoxia, Brain