Expired Study
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Nashville, Tennessee 37232


Purpose:

The hypothesis is that premature infants' can have enough cooling applied to cool their brain to decrease CNS injury without cooling their body.


Study summary:

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.


Criteria:

Inclusion Criteria: - Babies < 36 weeks gestation but > 32 0/7 weeks. These babies should be small enough to allow brain cooling with water circulating in a cooling cap applied to the surface of their head - At least one of the following four criteria which are standard definitions for HIE: - Apgar 0-3 at 1,5,10 minutes due to hypoxia - pH less than 7.0 - Base deficit greater than 15 - Need for continued resuscitation due to hypoxia at 10 minutes - AND a physical exam with evidence of hypotonia or lethargy or seizures indicative of evolving HIE. - Intubated - Age less than 6 hours - Signed informed consent by parent / legal guardian - Previous participant has been followed through 7 day head ultrasound. Exclusion Criteria: - Mild HIE will not be cooled, therefore babies without hypotonia or lethargy and babies who are not intubated will be excluded. - Gestational age ≥ 36 weeks or < 32 weeks or less than 1200 grams. - Older than 6 hours of age - Infant deemed in extremis on clinical exam. - Survival not expected, i.e. received 3 intravenous doses of epinephrine or more during resuscitation; on infusion of dopamine, dobutamine and/or epinephrine at time of evaluation; and/or has fixed/dilated pupils. - Evidence of head trauma or skull fracture causing major intracranial hemorrhage - Intraventricular hemorrhage - Weight less than the 5th percentile for gestational age - Refusal of consent - Imperforate anus


Study is Available At:


Original ID:

070984


NCT ID:

NCT00620711


Secondary ID:


Study Acronym:


Brief Title:

Pilot Study of Head Cooling in Preterm Infants With Hypoxic Ischemic Encephalopathy


Official Title:

IRB# 070984 "Pilot Study of Head Cooling in Preterm Infants With Hypoxic Ischemic Encephalopathy"


Overall Status:

Completed


Study Phase:

Phase 1


Genders:

N/A


Minimum Age:

N/A


Maximum Age:

6 Hours


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Vanderbilt University Medical Center


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

4


Enrollment Type:

Actual


Overall Contact Information

Official Name:Willaim F Walsh, MD
Principal Investigator
Vanderbilt University

Study Dates

Start Date:February 2008
Completion Date:July 2013
Completion Type:Actual
Primary Completion Date:July 2013
Primary Completion Type:Actual
Verification Date:January 2019
Last Changed Date:January 9, 2019
First Received Date:February 7, 2008
First Results Date:May 28, 2014

Study Outcomes

Outcome Type:Primary Outcome
Measure:Cap Cooled to 12 Degrees Without Reducing Rectal Temperature
Time Frame:6 hours
Safety Issues:False
Description:Yes/no
Outcome Type:Primary Outcome
Measure:Feasibility Trial- the Olympic Cool Cap Will be Applied, Can the Delivered Cap Temperature be Less Than 12 Degrees Without Changing Rectal Temperature.
Time Frame:60 minutes intervals up to 72 hours
Safety Issues:False
Description:Measurement of number of participants able to obtain 12 degree cap temperature

Study Interventions

Intervention Type:Device
Name:Olympic Cool Cap
Description:Olympic Cool Cap will be applied to infants 32-35 weeks gestation who meet criteria for HIE.
Arm Name:1
Other Name:Selective Head Cooling

Study Arms

Study Arm Type:Experimental
Arm Name:1
Description:Babies that meet criteria will be offered participation in feasibility trial, there are no other arms.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Vanderbilt University

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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