Brain Blood Flow and Cerebral Autoregulation Monitoring in Critically Ill Children

NCT07613918 | Not Yet Recruiting FDA Device

• 3 other identifiers: 2026-0238SMPH/Pediatrics/Critical CareProtocol Version 3/3/26
• Study Type: observational
• Target: 125
• Locations: 1 country
• Sites: 1

Brief Summary

This study uses a non-invasive (external) ultrasound test called Transcranial Doppler (TCD) to measure how blood flows through the major arteries of the brain of children receiving care in the Pediatric Intensive Care Unit (PICU). TCD is already used for clinical reasons in many children, but it is not part of routine monitoring for every critically ill child. By using TCD, the investigators hope to better understand how brain blood flow changes during illness. They will also track children's functional status from before their illness to the time of PICU discharge to explore how brain blood flow patterns relate to neurological outcomes.125 participants will be enrolled and will be on study while in the PICU, estimated to be 3-14 days.

Conditions

Cardiac Arrest; Critical Illness; Pediatric Critical Illness; Respiratory Failure; Traumatic Brain Injury

Keywords

PICU; infant; Transcranial Doppler Assessment; Cerebral Autoregulation; Blood Flow Velocity; children; mechanical ventilation; neurocritical care; pulsatility index; Mean flow index; neonate; pediatric critical care

Outcome Measures

Primary Outcomes (1)

• Change in Functional Status Scale (FSS) from baseline to PICU discharge

  To assess the relationship between cerebral autoregulation and neurological outcomes in critically ill pediatric patients, FSS will be measured. FSS has 6 domains: mental status, sensory, communication, motor function, feeding, and respiratory. FSS is scored from 6 to 30, higher scores are indicative of more severe dysfunction.

  Baseline FSS reflects pre-morbid functional status as reported by parents/guardians at enrollment; follow-up FSS assessed at PICU discharge (estimated 3-14 days)

Secondary Outcomes (6)

• Mean Flow Index (Mx)

  data collected while in PICU, from consent (baseline) to discharge (estimated 3-14 days)

• Percent successful exams (complete bilateral MCA data)

  data collected while in PICU, from consent (baseline) to discharge (estimated 3-14 days)

• Time per exam (min)

  data collected while in PICU, from consent (baseline) to discharge (estimated 3-14 days)

• Mean CBFV

  data collected while in PICU, from consent (baseline) to discharge (estimated 3-14 days)

• Age-stratified CBFV values across pre-specified clinical subgroups (TBI, cardiac arrest, ECMO)

  data collected while in PICU, from consent (baseline) to discharge (estimated 3-14 days)

Study Arms (1)

PICU Patients

Mechanically ventilated pediatric patients (1 day-17.5 years) admitted to the PICU.

Device: Transcranial Doppler

Interventions

Transcranial Doppler DEVICE

TCD measurements synchronized to arterial blood pressure and ventilatory data, performed once daily for up to 5 days during PICU admission plus one additional pre-extubation scan if applicable, approximately 30 minutes each. Bilateral middle cerebral artery (MCA) insonation performed at each session.

Also known as: TCD

PICU Patients

Eligibility Criteria

• Age: 1 Day - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Mechanically ventilated pediatric patients (1 day-17.5 years) admitted to the PICU who meet eligibility criteria

You may qualify if:

• Has at least one Parent or Legal Guardian who is willing and able to provide informed consent in English
• Mechanically ventilated (Endotracheal tube)
• Indwelling arterial catheter
• Current patient in the American Family Children's Hospital PICU.
• day to 17.5 years of age

You may not qualify if:

• Subjects with a known or obvious anatomic barrier preventing safe application of the transcranial Doppler probe (e.g., cranial dressings, cranial fixation hardware, ventricular access devices positioned over insonation sites, or bilateral craniectomies)
• Patient with known chronic hypertension
• Admission FSS score \> 16
• Tracheostomized patient
• The designated sub-investigator (Dr. Talal Al Hendawi) and PI (Dr. Neil Munjal) are unavailable to perform the Transcranial Doppler scan at the time of eligibility. All study scans are performed by either Dr. Al Hendawi or Dr.Munjal to ensure standardization and data integrity. Therefore, if they are unavailable (e.g., due to clinical service, leave, or other scheduling constraints), the patient will not be enrolled in the study.
• Not suitable for study participation due to other reasons at the discretion of the investigators

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

American Family Children's Hospital PICU

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

Critical Illness; Respiratory Insufficiency; Brain Injuries, Traumatic; Heart Arrest

Interventions

Ultrasonography, Doppler, Transcranial

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Respiratory Tract Diseases; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Echoencephalography; Neuroradiography; Neuroimaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Radiography; Ultrasonography; Ultrasonography, Doppler; Diagnostic Techniques, Neurological; Investigative Techniques

Study Officials

• Neil Munjal, MD

  UW School of Medicine and Public Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Meg Baker

CONTACT

meg.baker@wisc.edu; meg.baker@wisc.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2026
• First Posted: May 29, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2028
• Last Updated: June 4, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)