Whole Body Cooling Using Phase Changing Material

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by Robertson, Nicola, M.D..
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Thayyil, Sudhin
Information provided by:
Robertson, Nicola, M.D.
ClinicalTrials.gov Identifier:
NCT01138176
First received: June 2, 2010
Last updated: June 3, 2010
Last verified: June 2010
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase II Randomized Control Trial of Whole Body Cooling in Neonatal Encephalopathy Using Phase Changing Material

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Stability of cooling [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    Basal ganglia, white matter and cortical lesions scored from 0 to 3

  • Adverse neurodevelopment [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    Death until hospital discharge

  • EEG abnormality [ Time Frame: 4 days ] [ Designated as safety issue: No ]
    Abnormal background activity

  • Sepsis [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]
    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

Ages Eligible for Study:   up to 24 Hours
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

Responsible Party: Nicola Robertson, Reader in Translational Neonatal Medicine
ClinicalTrials.gov Identifier: NCT01138176     History of Changes
Other Study ID Numbers: PCM09
Study First Received: June 2, 2010
Last Updated: June 3, 2010
Health Authority: United Kingdom: National Health Service

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

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

ClinicalTrials.gov processed this record on August 28, 2014