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| Sponsored by: |
Vanderbilt University |
|---|---|
| Information provided by: | Vanderbilt University |
| ClinicalTrials.gov Identifier: | NCT00620711 |
Purpose
The hypothesis is that premature infants' can have enough cooling applied to cool their brain to decrease CNS injury without cooling their body.
| Condition | Intervention | Phase |
|---|---|---|
|
Hypoxic Ischemic Encephalopathy |
Device: Olympic Cool Cap |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label, Single Group Assignment, Safety Study |
| Official Title: | IRB# 070984 "Pilot Study of Head Cooling in Preterm Infants With Hypoxic Ischemic Encephalopathy" |
| Estimated Enrollment: | 5 |
| Study Start Date: | February 2008 |
| Estimated Study Completion Date: | February 2009 |
| Estimated Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Babies that meet criteria will be offered participation in feasibility trial, there are no other arms.
|
Device: Olympic Cool Cap
Olympic Cool Cap will be applied to infants 32-35 weeks gestation who meet criteria for HIE.
|
Hypoxic ischemic encephalopathy (HIE) is a potentially devastating disease of the newborn central nervous system (CNS) . Portions of the CNS are deprived of oxygen and blood flow for a period of time which may lead to permanent brain injury manifested as cerebral palsy as well as cognitive defects. Until recently no treatment has been shown to be effective for preventing brain damage, even though it has been demonstrated that the damage is progressive and that there is a window of opportunity to arrest some of the evolving brain injury. However, in May of 2007 the FDA approved the first device specifically designed to ameliorate brain damage in term babies with HIE. This head cooling device which was studied here at Vanderbilt under IRB protocol 990129 Brain Cooling for the treatment of perinatal hypoxic ischemic encephalopathy. We thus have eight years of experience of using this device in term infants. The results of the initial trial demonstrated a successful reduction of HIE induced brain injury from 66% in control infants to 55% in treated babies. There were no significant risks to the application of this device in term babies who are kept cool for 72 hours after experiencing an acute HIE event. The initial trials were limited to term babies because of concern that premature infants would be more at risk for hypothermia induced problems such as hypoglycemia,and coagulopathy. The concern about hypothermia in preterm infants remains a limiting consideration for doing whole body cooling in this population. We propose to apply the cooling cap to the heads of preterm infants who have experienced a significant HIE injury but maintain their body temperature in the normal range (36.1-37° C rectally). Infants will be cooled for up to 72 hours and will be tracked till discharge. Although this is a feasibility study, the participants will also be followed-up at 6, 12 and 24 months of age.
Eligibility| Ages Eligible for Study: | up to 6 Hours |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
At least one of the following four criteria which are standard definitions for HIE:
Exclusion Criteria:
Contacts and Locations| Contact: Willaim F Walsh, MD | 615 3220545 | bill.walsh@vanderbilt.edu |
| Contact: John Schmidt, MD | 615 3223476 | john.schmidt@vanderbilt.edu |
| United States, Tennessee | |
| Monroe Carell Jr Children's Hospital | Recruiting |
| Nashville, Tennessee, United States, 37232 | |
| Principal Investigator: William F Walsh, MD | |
| Principal Investigator: | Willaim F Walsh, MD | Vanderbilt University |
More Information
| Responsible Party: | Vanderbilt University Medical center ( William F Walsh ) |
| Study ID Numbers: | 070984 |
| Study First Received: | February 7, 2008 |
| Last Updated: | September 5, 2008 |
| ClinicalTrials.gov Identifier: | NCT00620711 |
| Health Authority: | United States: Food and Drug Administration |
|
Hypoxic ischemic encephalopathy HIE Neonatal encephalopathy Cooling hypothermia |
|
Liver Diseases Neurotoxicity Syndromes Hypoxia, Brain Brain Damage, Chronic Disorders of Environmental Origin Brain Diseases Cerebrovascular Disorders Signs and Symptoms Hypoxia-Ischemia, Brain Mental Disorders Brain Ischemia Brain Injuries Dementia Neurobehavioral Manifestations Hepatic Insufficiency |
Delirium Hypothermia Liver Failure Metabolic Diseases Neurotoxicity syndromes Poisoning Vascular Diseases Central Nervous System Diseases Confusion Ischemia Encephalitis Cognition Disorders Virus Diseases Hepatic Encephalopathy Digestive System Diseases |
|
Pathologic Processes Nervous System Diseases Central Nervous System Viral Diseases Cardiovascular Diseases |
