Clinical trial NCT01138176: Whole Body Cooling Using Phase Changing Material
Official title: Phase II Randomized Control Trial of Whole Body Cooling in Neonatal Encephalopathy Using Phase Changing Material
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Hypoxic Ischemic Encephalopathy
Keywords: Neonatal encephalopathy
Therapeutic hypothermia
Phase changing material
MR imaging
Lead sponsor: Robertson, Nicola, M.D.
Sponsor class: INDIV
Collaborators: name: Thayyil, Sudhin
First posted: 2010-06-07
Enrollment: 35
Sex: ALL
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Stability of cooling
timeFrame: 72 hours
Secondary outcomes:
measure: Brain tissue injury on MR imaging
timeFrame: 7 to 10 days
measure: Adverse neurodevelopment
timeFrame: 12 months
measure: Mortality
timeFrame: 4 weeks
measure: EEG abnormality
timeFrame: 4 days
measure: Sepsis
timeFrame: 1 week
Other outcomes:
Locations:
city: Calicut
country: India
facility: Calicut Medical College
Study officials:
affiliation: Calicut Medical College
name: Balraj Guhan, MD
role: PRINCIPAL_INVESTIGATOR
References: