Hypoxic Ischemic Encephalopathy Clinical Trial
Official title:
IRB# 070984 "Pilot Study of Head Cooling in Preterm Infants With Hypoxic Ischemic Encephalopathy"
NCT number | NCT00620711 |
Other study ID # | 070984 |
Secondary ID | |
Status | Completed |
Phase | Phase 1 |
First received | |
Last updated | |
Start date | February 2008 |
Est. completion date | July 2013 |
Verified date | January 2019 |
Source | Vanderbilt University Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The hypothesis is that premature infants' can have enough cooling applied to cool their brain to decrease CNS injury without cooling their body.
Status | Completed |
Enrollment | 4 |
Est. completion date | July 2013 |
Est. primary completion date | July 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 6 Hours |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Monroe Carell Jr Children's Hospital | Nashville | Tennessee |
Lead Sponsor | Collaborator |
---|---|
Vanderbilt University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 60 minutes intervals up to 72 hours | |
Primary | Cap Cooled to 12 Degrees Without Reducing Rectal Temperature | Yes/no | 6 hours |
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