Status:
COMPLETED
Pilot Study of Head Cooling in Preterm Infants With Hypoxic Ischemic Encephalopathy
Lead Sponsor:
Vanderbilt University
Conditions:
Hypoxic Ischemic Encephalopathy
Eligibility:
All Genders
30-6 years
Phase:
PHASE1
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT00620711
Start Date
February 1 2008
End Date
July 1 2013
Last Update
January 29 2019
Active Locations (1)
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1
Monroe Carell Jr Children's Hospital
Nashville, Tennessee, United States, 37232