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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
William Walsh, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00620711
First received: February 7, 2008
Last updated: July 30, 2014
Last verified: July 2014
  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 1

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"

Resource links provided by NLM:


Further study details as provided by Vanderbilt University:

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. [ Time Frame: 60 minutes intervals ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    Yes/no


Enrollment: 4
Study Start Date: February 2008
Study Completion Date: July 2013
Primary Completion Date: July 2013 (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

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.

  Eligibility

Ages Eligible for Study:   up to 6 Hours
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00620711

Locations
United States, Tennessee
Monroe Carell Jr Children's Hospital
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
Investigators
Principal Investigator: Willaim F Walsh, MD Vanderbilt University
  More Information

No publications provided by Vanderbilt University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: William Walsh, Professor of Pediatrics, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00620711     History of Changes
Other Study ID Numbers: 070984
Study First Received: February 7, 2008
Results First Received: May 28, 2014
Last Updated: July 30, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Vanderbilt University:
Hypoxic ischemic encephalopathy
HIE
Neonatal encephalopathy
Cooling
hypothermia

Additional relevant MeSH terms:
Brain Ischemia
Ischemia
Brain Diseases
Hypoxia-Ischemia, Brain
Cerebrovascular Disorders
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Hypoxia, Brain

ClinicalTrials.gov processed this record on August 28, 2014