Hypoxic Ischemic Encephalopathy
Conditions
Keywords
Neonatal encephalopathy, Therapeutic hypothermia, Phase changing material, MR imaging
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.
Interventions
PROCEDURECooling
Reduction of rectal temperature to 33.5 C
Sponsors
Thayyil, Sudhin
Robertson, Nicola, M.D.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 24 Hours
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stability of cooling | 72 hours | Percentage of time for which rectal temperature is maintained between 33 to 34 C during the 72 hours of therapeutic hypothermia |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Brain tissue injury on MR imaging | 7 to 10 days | Basal ganglia, white matter and cortical lesions scored from 0 to 3 |
| Adverse neurodevelopment | 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 | 4 weeks | Death until hospital discharge |
| EEG abnormality | 4 days | Abnormal background activity |
| Sepsis | 1 week | Blood or CSF culture positive sepsis |
Countries
India
Outcome results
None listed