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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00620711
• Date of registration: 07/02/2008
• Primary sponsor: Vanderbilt University
• Public title: Pilot Study of Head Cooling in Preterm Infants With Hypoxic Ischemic Encephalopathy
• Scientific title: IRB# 070984 "Pilot Study of Head Cooling in Preterm Infants With Hypoxic Ischemic Encephalopathy"
• Date of first enrolment: February 2008
• Target sample size: 5
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT00620711
• Study type: Interventional
• Study design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: William F Walsh, MD

• Name: Willaim F Walsh, MD
• Affiliation: Vanderbilt University

Key inclusion & exclusion 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



Age minimum: N/A
Age maximum: 6 Hours
Gender: Both

Health Condition(s) or Problem(s) studied

Hypoxic Ischemic Encephalopathy

Intervention(s)

Device: Olympic Cool Cap

Primary Outcome(s)

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: 60 minutes intervals]

Secondary ID(s)

070984

Source(s) of Monetary Support

Please refer to primary and secondary sponsors