RECRUITING

Multimodal Monitoring of Cerebral Autoregulation After Pediatric Brain Injury

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Various methods have been studied to evaluate autoregulation. However, there is currently no universally accepted technique to assess integrity of the cerebral autoregulation neurovascular system. In the last decade, significant progress has been achieved in developing methods to assess cerebral autoregulation by quantifying cross-correlation between spontaneous oscillations in CBF or oxygenation and similar oscillations in arterial blood pressure. In this study the investigators will analyze the relationship between spontaneous fluctuations in mean arterial blood pressure and cerebral blood flow velocity or cerebral regional oxygenation to investigate two novel methods for measuring cerebral autoregulation, Transfer Function Analysis and Wavelet Coherence after acute pediatric brain injury.

Official Title

Multimodal Monitoring of Cerebral Autoregulation After Pediatric Brain Injury

Quick Facts

Study Start:2018-11-06
Study Completion:2025-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04242602

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:28 Days to 18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Ages 28 days-18 years admitted to the PICU at Children's Medical Center Dallas
  2. * Acute presentation (\< 24 hour) onset of neurologic injury
  3. * Acute neurologic injury can be due to any of the following mechanisms:
  4. * Severe accidental or abusive traumatic brain injury
  5. * Severe encephalopathy secondary to cardiac arrest
  6. * Spontaneous intracranial hemorrhage
  7. * Status epilepticus
  8. * Stroke
  9. * Presence of or pending placement of invasive indwelling arterial line for stand medical care
  10. * Any patient with an ICP monitor placed as standard of care
  1. * Patients without an arterial line placed as standard of care
  2. * Patients unable to cooperate with wearing a TCD headpiece device
  3. * Expected death within 24-48 hours
  4. * Inability to place NIRS probes or insonate TCD signal due to massive facial or cranial injury
  5. * Receiving an inhalational anesthetic agent
  6. * Hemoglobinopathy, myoglobinemia or and hyperbilirubinemia (due to inaccurate NIRS readings)

Contacts and Locations

Study Contact

Danyal Thaver
CONTACT
2144567592
danyal.thaver@utsouthwestern.edu

Principal Investigator

Darryl Miles
PRINCIPAL_INVESTIGATOR
University of Texas Southwestern Medical Center

Study Locations (Sites)

Children's Medical Center
Dallas, Texas, 75390
United States

Collaborators and Investigators

Sponsor: University of Texas Southwestern Medical Center

  • Darryl Miles, PRINCIPAL_INVESTIGATOR, University of Texas Southwestern Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-11-06
Study Completion Date2025-01

Study Record Updates

Study Start Date2018-11-06
Study Completion Date2025-01

Terms related to this study

Additional Relevant MeSH Terms

  • Traumatic Brain Injury
  • Brain Injuries
  • Brain Injury, Vascular