Pilot Study of Head Cooling in Preterm Infants With Hypoxic Ischemic Encephalopathy
Primary Purpose
Hypoxic Ischemic Encephalopathy
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Olympic Cool Cap
Sponsored by
About this trial
This is an interventional treatment trial for Hypoxic Ischemic Encephalopathy focused on measuring Hypoxic ischemic encephalopathy, HIE, Neonatal encephalopathy, Cooling, hypothermia
Eligibility 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
Sites / Locations
- Monroe Carell Jr Children's Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Babies that meet criteria will be offered participation in feasibility trial, there are no other arms.
Outcomes
Primary Outcome Measures
Feasibility Trial- the Olympic Cool Cap Will be Applied, Can the Delivered Cap Temperature be Less Than 12 Degrees Without Changing Rectal Temperature.
Measurement of number of participants able to obtain 12 degree cap temperature
Cap Cooled to 12 Degrees Without Reducing Rectal Temperature
Yes/no
Secondary Outcome Measures
Full Information
NCT ID
NCT00620711
First Posted
February 7, 2008
Last Updated
January 9, 2019
Sponsor
Vanderbilt University
1. Study Identification
Unique Protocol Identification Number
NCT00620711
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"
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The hypothesis is that premature infants' can have enough cooling applied to cool their brain to decrease CNS injury without cooling their body.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoxic Ischemic Encephalopathy
Keywords
Hypoxic ischemic encephalopathy, HIE, Neonatal encephalopathy, Cooling, hypothermia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Babies that meet criteria will be offered participation in feasibility trial, there are no other arms.
Intervention Type
Device
Intervention Name(s)
Olympic Cool Cap
Other Intervention Name(s)
Selective Head Cooling
Intervention Description
Olympic Cool Cap will be applied to infants 32-35 weeks gestation who meet criteria for HIE.
Primary Outcome Measure Information:
Title
Feasibility Trial- the Olympic Cool Cap Will be Applied, Can the Delivered Cap Temperature be Less Than 12 Degrees Without Changing Rectal Temperature.
Description
Measurement of number of participants able to obtain 12 degree cap temperature
Time Frame
60 minutes intervals up to 72 hours
Title
Cap Cooled to 12 Degrees Without Reducing Rectal Temperature
Description
Yes/no
Time Frame
6 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Minutes
Maximum Age & Unit of Time
6 Hours
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Willaim F Walsh, MD
Organizational Affiliation
Vanderbilt University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Monroe Carell Jr Children's Hospital
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
24524452
Citation
Shankaran S. Outcomes of hypoxic-ischemic encephalopathy in neonates treated with hypothermia. Clin Perinatol. 2014 Mar;41(1):149-59. doi: 10.1016/j.clp.2013.10.008.
Results Reference
derived
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Pilot Study of Head Cooling in Preterm Infants With Hypoxic Ischemic Encephalopathy
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