Whole Body Cooling Using Phase Changing Material
Recruitment status was Active, not recruiting
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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 |
- 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
- 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:
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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:
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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 |
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 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 Damage, Chronic Delirium Encephalitis Hepatic Encephalopathy Neurotoxicity Syndromes Hypoxia-Ischemia, Brain Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases Confusion Neurobehavioral Manifestations |
Neurologic Manifestations Signs and Symptoms Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Central Nervous System Viral Diseases Virus Diseases Central Nervous System Infections Liver Failure Hepatic Insufficiency Liver Diseases Digestive System Diseases Brain Diseases, Metabolic Metabolic Diseases Poisoning Substance-Related Disorders |
ClinicalTrials.gov processed this record on May 22, 2013