Whole Body Cooling Using Phase Changing Material

Hypoxic Ischemic Encephalopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01138176
• Other study ID #: PCM09
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• First received: June 2, 2010
• Last updated: June 3, 2010
• Start date: July 2009
• Est. completion date: August 2011

Study information

• Verified date: June 2010
• Source: Robertson, Nicola, M.D.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 35
• Est. completion date: August 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 24 Hours

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Diseases
• Brain Ischemia
• Hypoxia-Ischemia, Brain
• Hypoxic Ischemic Encephalopathy

Intervention

Procedure:
• Cooling
Reduction of rectal temperature to 33.5 C

Locations

Country	Name	City	State
India	Calicut Medical College	Calicut

Sponsors (2)

Lead Sponsor	Collaborator
Robertson, Nicola, M.D.	Thayyil, Sudhin

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Brain tissue injury on MR imaging	Basal ganglia, white matter and cortical lesions scored from 0 to 3	7 to 10 days	Yes
Secondary	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	No
Secondary	Mortality	Death until hospital discharge	4 weeks	Yes
Secondary	EEG abnormality	Abnormal background activity	4 days	No
Secondary	Sepsis	Blood or CSF culture positive sepsis	1 week	Yes

External Links

•   UCL Institute for Women's Health