Whole Body Cooling Using Phase Changing Material

Study Overview
=================
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.

Official Title
-----------------
Phase II Randomized Control Trial of Whole Body Cooling in Neonatal Encephalopathy Using Phase Changing Material

Conditions
-----------------
Hypoxic Ischemic Encephalopathy

Intervention / Treatment
-----------------
* Procedure: Cooling


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Maximum Age: 24 Hours

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard care<br> | Procedure: Cooling<br>* Reduction of rectal temperature to 33.5 C<br>* Other names: Whole body cooling;|
| Experimental: Cooling<br>Reduction of rectal temperature to 33.5 C for 72 hours | Procedure: Cooling<br>* Reduction of rectal temperature to 33.5 C<br>* Other names: Whole body cooling;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stability of cooling | Percentage of time for which rectal temperature is maintained between 33 to 34 C during the 72 hours of therapeutic hypothermia | 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brain tissue injury on MR imaging | Basal ganglia, white matter and cortical lesions scored from 0 to 3 | 7 to 10 days | 
| Adverse neurodevelopment | 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 | 12 months | 
| Mortality | Death until hospital discharge | 4 weeks | 
| EEG abnormality | Abnormal background activity | 4 days | 
| Sepsis | Blood or CSF culture positive sepsis | 1 week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Neonatal encephalopathy, Therapeutic hypothermia, Phase changing material, MR imaging