Hypoxic Ischemic Encephalopathy Clinical Trial
Official title:
Phase II Randomized Control Trial of Whole Body Cooling in Neonatal Encephalopathy Using Phase Changing Material
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.
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.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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