Whole Body Cooling Using Phase Changing Material

Status Active, not recruiting

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.

Clinical Trial 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 Design

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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01138176
Study type	Interventional
Source	Robertson, Nicola, M.D.
Contact
Status	Active, not recruiting
Phase	Phase 1/Phase 2
Start date	July 2009
Completion date	August 2011

View Details

See also
Status	Clinical Trial	Phase
Withdrawn	`NCT02551003` - Neuroprotective Effect of Autologous Cord Blood Combined With Therapeutic Hypothermia Following Neonatal Encephalopathy	Phase 1/Phase 2
Completed	`NCT02683915` - Reno-protective Effect of Brain Cooling in Newborn With Hypoxia
Recruiting	`NCT01962233` - Umbilical Cord Derived Mesenchymal Stem Cells Therapy in Hypoxic Ischemic Encephalopathy	Phase 1
Completed	`NCT01471015` - Darbe Administration in Newborns Undergoing Cooling for Encephalopathy	Phase 1/Phase 2
Completed	`NCT01683383` - California Transport Cooling Trial	N/A
Completed	`NCT01481207` - Magnetic Resonance Imaging and Spectroscopy Biomarkers of Neonatal Hypoxic Ischemic Encephalopathy
Completed	`NCT01649648` - Autologous Cord Blood Cells for Brain Injury in Term Newborns	Phase 1
Withdrawn	`NCT00993564` - Magnetic Resonance Imaging (MRI) Thermal Imaging of Infants Undergoing Cooling for Hypoxic Ischemic Encephalopathy (HIE)	N/A
Completed	`NCT00945789` - Erythropoietin in Infants With Hypoxic Ischemic Encephalopathy (HIE)	Phase 1/Phase 2
Completed	`NCT00097097` - Neonatal Resuscitation in Zambia	Phase 3
Recruiting	`NCT02621944` - Melatonin as a Neuroprotective Therapy in Neonates With HIE Undergoing Hypothermia	Early Phase 1
Not yet recruiting	`NCT02605018` - Neuroprotective Effect of Autologous Cord Blood Combined With Therapeutic Hypothermia Following Neonatal Encephalopathy	Phase 1/Phase 2
Withdrawn	`NCT01128673` - MRI Thermal Imaging of Infants Undergoing Cooling for Hypoxic Ischemic Encephalopathy(HIE)	N/A
Completed	`NCT01732146` - Efficacy of Erythropoietin to Improve Survival and Neurological Outcome in Hypoxic Ischemic Encephalopathy	Phase 3
Completed	`NCT02349672` - Clinical Utility of Serum Biomarkers for the Management of Neonatal Hypoxic Ischemic Encephalopathy (Control Levels)
Completed	`NCT02826941` - Moderate Hypothermia in Neonatal Hypoxic Ischemic Encephalopathy	Phase 2
Recruiting	`NCT02578823` - Targeted Temperature Management After In-Hospital Cardiac Arrest	N/A
Terminated	`NCT01765218` - Topiramate in Neonates Receiving Whole Body Cooling for Hypoxic Ischemic Encephalopathy	Phase 1/Phase 2
Completed	`NCT01241019` - Safety and Efficacy of Topiramate in Neonates With Hypoxic Ischemic Encephalopathy Treated With Hypothermia	Phase 2
Completed	`NCT00620711` - Pilot Study of Head Cooling in Preterm Infants With Hypoxic Ischemic Encephalopathy	Phase 1

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.