Whole Body Cooling Using Phase Changing Material

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

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.

Study Overview

• Status: Unknown
• Conditions: Hypoxic Ischemic Encephalopathy
• Intervention / Treatment: Procedure: Cooling

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.

• Study Type: Interventional
• Enrollment (Anticipated): 35
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• India
  • Calicut, India
    • Calicut Medical College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 1 day (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard care	Procedure: Cooling; Reduction of rectal temperature to 33.5 C; Other Names: Therapeutic hypothermia; Whole body cooling
Experimental: Cooling; Reduction of rectal temperature to 33.5 C for 72 hours	Procedure: Cooling; Reduction of rectal temperature to 33.5 C; Other Names: Therapeutic hypothermia; 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

Collaborators and Investigators

• Sponsor: Robertson, Nicola, M.D.
• Collaborators: Thayyil, Sudhin
• Investigators: Principal Investigator: Balraj Guhan, MD, Calicut Medical College

Publications and helpful links

Helpful Links

• UCL Institute for Women's Health

Study record dates

Study Major Dates

• Study Start: July 1, 2009
• Primary Completion (Anticipated): January 1, 2011
• Study Completion (Anticipated): August 1, 2011

Study Registration Dates

• First Submitted: June 2, 2010
• First Submitted That Met QC Criteria: June 3, 2010
• First Posted (Estimate): June 7, 2010

Study Record Updates

• Last Update Posted (Estimate): June 7, 2010
• Last Update Submitted That Met QC Criteria: June 3, 2010
• Last Verified: June 1, 2010

More Information

Terms related to this study

• Keywords: Therapeutic hypothermia; Neonatal encephalopathy; MR imaging; Phase changing material
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Central Nervous System Diseases; Nervous System Diseases; Signs and Symptoms, Respiratory; Hypoxia; Hypoxia, Brain; Brain Ischemia; Brain Diseases; Hypoxia-Ischemia, Brain
• Other Study ID Numbers: PCM09