Cerebral Oxygen Metabolism in Children

NCT04157179 | Recruiting

• 1 other identifier: 201905044
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research study is to better understand how blood flow and metabolism change can influence brain development in the early decades of life. We will examine brain blood flow and metabolism using magnetic resonance imaging (MRI). The brain's blood vessels expand and constrict to regulate blood flow based on the brain's needs. The amount of expanding and contracting the blood vessels can do varies by age. The brain's blood flow changes in small ways during everyday activities, such as normal brain growth, exercise, or deep concentration. Significant illness or psychological stress may increase the brain's metabolic demand or cause other bigger changes in blood flow. If blood vessels are not able to expand to give more blood flow when metabolic demand is high, the brain may not get all of the oxygen it needs. In extreme circumstances, if the brain is unable to get enough oxygen for a long time, a stroke may occur. Sometimes small strokes occur without other noticeable changes and are only detectable on an MRI. These are sometimes called "silent strokes." In less extreme circumstances, not having as much oxygen as it wants may cause the brain to grow and develop more slowly than it should. One way to test the ability of blood vessels to expand is by measuring blood flow while breathing in carbon dioxide. Carbon dioxide causes blood vessels in the brain to dilate without increasing brain metabolism. During this study participants may be asked to undergo a blood draw, MRI, and potential neuropsychological assessments. It is also possible that the study team will use a special mask to control the amount of carbon dioxide the participants breathe in so they don't breathe in too much.

Conditions

Sickle Cell Disease; Cerebral Stroke

Keywords

extracorporeal membrane oxygenation; cerebrovascular reactivity; sickle cell disease; healthy controls; magnetic resonance imaging

Outcome Measures

Primary Outcomes (1)

• Cerebral Oxygen Metabolism

  From the beginning of the MRI scan to the completion of the MRI scan -- 75 minutes.

Secondary Outcomes (1)

• Cerebrovascular Reactivity

  From administration of carbon dioxide to end of inhalation of carbon dioxide -- 15 minutes.

Study Arms (3)

Healthy Controls

ACTIVE COMPARATOR

Other: Carbon Dioxide

Extracorporeal Membrane Oxygenation survivors

ACTIVE COMPARATOR

Other: Carbon Dioxide

Sickle Cell Anemia participants

ACTIVE COMPARATOR

Other: Carbon Dioxide

Interventions

Carbon Dioxide OTHER

Participants inhale carbon dioxide while in magnetic resonance imaging scan to measure cerebrovascular reactivity

Extracorporeal Membrane Oxygenation survivors; Healthy Controls; Sickle Cell Anemia participants

Eligibility Criteria

• Age: 3 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

Healthy Controls: * Healthy controls ages 3-50 years of age * Able to participate in MRI scan without sedation * Not currently pregnant * No significant psychiatric history, defined as having a severe psychiatric diagnosis, per PI discretion * No history of epilepsy * No history of stroke or cerebrovascular disease * May have occasional headaches if not taking a daily preventative medication for headaches * Not on vasodilatory medication, such as sildenafil or verapamil Sickle Cell Anemia Participants: * Ages 3-50 years of age * Hb SS or SBeta-thal * Able to participate in MRI scan without sedation * Not currently pregnant * Not on vasodilatory medication, such as sildenafil or verapamil Extracorporeal Membrane Oxygenation (ECMO) Survivors: * Ages 3-50 years of age * History of cannulation for ECMO * Able to participate in MRI scan without sedation * Not currently pregnant * Not on vasodilatory medication, such as sildenafil or verapamil

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University of St. Louis

St Louis, Missouri, 63110, United States

RECRUITING

MeSH Terms

Conditions

Anemia, Sickle Cell; Stroke

Interventions

Carbon Dioxide

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Carbon Compounds, Inorganic; Inorganic Chemicals; Gases; Oxides; Oxygen Compounds

Central Study Contacts

Kristin Guilliams, MD

CONTACT

3144546120; kristinguilliams@wustl.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All arms will receive the same study conditions.

Study Record Dates

• First Submitted: November 6, 2019
• First Posted: November 8, 2019
• Study Start: October 17, 2019
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: September 11, 2025

Record last verified: 2025-09

Locations

US (1)