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| Sponsor: | 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: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 2013 |
| Estimated Primary Completion Date: | February 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
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.
Other Name: Selective Head Cooling
|
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: William F Walsh, MD | 615 3220545 | bill.walsh@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: | William F Walsh, Vanderbilt University Medical center |
| ClinicalTrials.gov Identifier: | NCT00620711 History of Changes |
| Other Study ID Numbers: | 070984 |
| Study First Received: | February 7, 2008 |
| Last Updated: | March 21, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
Hypoxic ischemic encephalopathy HIE Neonatal encephalopathy Cooling hypothermia |
|
Brain Ischemia Ischemia Brain Damage, Chronic Delirium Encephalitis Hepatic Encephalopathy Neurotoxicity Syndromes Hypoxia-Ischemia, Brain Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases Pathologic Processes |
Confusion Neurobehavioral Manifestations Neurologic Manifestations Signs and Symptoms Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Central Nervous System Viral Diseases Virus Diseases Central Nervous System Infections Liver Failure Hepatic Insufficiency Liver Diseases Digestive System Diseases Brain Diseases, Metabolic Metabolic Diseases |
