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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00620711
Recruitment Status : Completed
First Posted : February 21, 2008
Results First Posted : July 31, 2014
Last Update Posted : January 29, 2019
Information provided by (Responsible Party):
William Walsh, Vanderbilt University

Tracking Information
First Submitted Date  ICMJE February 7, 2008
First Posted Date  ICMJE February 21, 2008
Results First Submitted Date  ICMJE May 28, 2014
Results First Posted Date  ICMJE July 31, 2014
Last Update Posted Date January 29, 2019
Study Start Date  ICMJE February 2008
Actual Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 9, 2019)
  • 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 ]
    Measurement of number of participants able to obtain 12 degree cap temperature
  • Cap Cooled to 12 Degrees Without Reducing Rectal Temperature [ Time Frame: 6 hours ]
Original Primary Outcome Measures  ICMJE
 (submitted: February 7, 2008)
Feasibility trial- the Olympic Cool Cap will be applied, can the delivered cap temperature be less than 20 degrees without changing rectal temperature. [ Time Frame: 15 minutes ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Pilot Study of Head Cooling in Preterm Infants With Hypoxic Ischemic Encephalopathy
Official Title  ICMJE IRB# 070984 "Pilot Study of Head Cooling in Preterm Infants With Hypoxic Ischemic Encephalopathy"
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hypoxic Ischemic Encephalopathy
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: 1
Babies that meet criteria will be offered participation in feasibility trial, there are no other arms.
Intervention: Device: Olympic Cool Cap
Publications * 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. Review.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 30, 2014)
Original Estimated Enrollment  ICMJE
 (submitted: February 7, 2008)
Actual Study Completion Date  ICMJE July 2013
Actual Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 6 Hours   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00620711
Other Study ID Numbers  ICMJE 070984
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party William Walsh, Vanderbilt University
Study Sponsor  ICMJE Vanderbilt University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Willaim F Walsh, MD Vanderbilt University
PRS Account Vanderbilt University Medical Center
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP