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

NCT00620711 | Completed Phase 1 Results DMC

• 1 other identifier: 070984
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypoxic Ischemic Encephalopathy

Keywords

Hypoxic ischemic encephalopathy; HIE; Neonatal encephalopathy; Cooling; hypothermia

Outcome Measures

Primary Outcomes (2)

• 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

• Cap Cooled to 12 Degrees Without Reducing Rectal Temperature

  Yes/no

  6 hours

Study Arms (1)

1

EXPERIMENTAL

Babies that meet criteria will be offered participation in feasibility trial, there are no other arms.

Device: Olympic Cool Cap

Interventions

Olympic Cool Cap DEVICE

Olympic Cool Cap will be applied to infants 32-35 weeks gestation who meet criteria for HIE.

Also known as: Selective Head Cooling

1

Eligibility Criteria

• Age: 30 Minutes - 6 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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

Sponsors & Collaborators

• Vanderbilt University: lead

Study Sites (1)

Monroe Carell Jr Children's Hospital

Nashville, Tennessee, 37232, United States

Location

Related Publications (1)

• Shankaran S. Outcomes of hypoxic-ischemic encephalopathy in neonates treated with hypothermia. Clin Perinatol. 2014 Mar;41(1):149-59. doi: 10.1016/j.clp.2013.10.008.

  PMID: 24524452 DERIVED

MeSH Terms

Conditions

Hypoxia-Ischemia, Brain; Hypothermia

Condition Hierarchy (Ancestors)

Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypoxia, Brain; Vascular Diseases; Cardiovascular Diseases; Hypoxia; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Temperature Changes

Results Point of Contact

• Title: William F Walsh
• Organization: Vanderbilt university

bill.walsh@vanderbilt.edu

615-322-0545

Study Officials

• Willaim F Walsh, MD

  Vanderbilt University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics

Study Record Dates

• First Submitted: February 7, 2008
• First Posted: February 21, 2008
• Study Start: February 1, 2008
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: January 29, 2019
• Results First Posted: July 31, 2014

Record last verified: 2019-01

Locations

US (1)