Whole Body Cooling Using Phase Changing Material

Robertson, Nicola, M.D.

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Hypoxic Ischemic Encephalopathy

Treatments: Procedure: Cooling

Study type: Interventional

Identifiers

NCT01138176

PCM09

Details and patient eligibility

About

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.

Full 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.

Enrollment: 35 estimated patients

Sex: All

Ages: Under 24 hours old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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35 participants in 2 patient groups

Standard care

No Intervention group

Treatment:

Procedure: Cooling

Cooling

Experimental group

Description:

Reduction of rectal temperature to 33.5 C for 72 hours

Treatment:

Procedure: Cooling