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

Completed · Phase 1

Conditions studied: Hypoxic Ischemic Encephalopathy

In brief

The hypothesis is that premature infants' can have enough cooling applied to cool their brain to decrease CNS injury without cooling their body.

Key facts

Study ID

NCT00620711

Run by

Vanderbilt University

People needed

4

Starts

2008-02-01

Expected to finish

2013-07-01

Last updated by the study team

2019-01-29

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Monroe Carell Jr Children's Hospital — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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