Near Infrared Spectroscopy in Sickle Cell Pediatric Patients

NCT04031521 | Withdrawn FDA Device

• 1 other identifier: Pro00012424
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Endothelial dysfunction contributes to vaso-occlusion and acute pain in sickle cell disease. Near infrared spectroscopy (NIRS) technology can measure tissue oxygenation and endothelial function. The main objective of this study is to study the natural history of tissue muscle oxygenation using NIRS in pediatric sickle cell subjects experiencing acute pain and pediatric sickle cell patients in steady-state.

Conditions

Sickle Cell Disease

Outcome Measures

Primary Outcomes (1)

• Tissue oxygenation

  6 months

Secondary Outcomes (1)

• Nitric oxide

  6 months

Study Arms (2)

Sickle cell pain crisis

Diagnostic Test: Near infrared spectroscopy

Sickle cell steady-state

Diagnostic Test: Near infrared spectroscopy

Interventions

Near infrared spectroscopy DIAGNOSTIC_TEST

NIRS is an emerging technology for measuring tissue oxygenation and endothelial function. NIRS light can penetrate through biological tissues, including skin, bone, and muscle. Similar to other optical methods, light is applied to the region of interest and undergoes scattering and absorption before being detected by a photosensor. This technique is commonly used to assess oxygen availability and consumption in living tissues. Using different wavelengths, NIRS can differentiate between oxygenated and deoxygenated hemoglobin in blood and can measure changes in total hemoglobin concentration, using the sum of oxygenated and deoxygenated hemoglobin.

Sickle cell pain crisis; Sickle cell steady-state

Eligibility Criteria

• Age: 6 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Subjects 6 to 21 years of age of all sickle cell genotypes

You may qualify if:

• Age 6 to 21 years old.
• Diagnosis of sickle cell anemia: a. Diagnosis of sickle cell disease (electrophoresis or HPLC documentation of hemoglobin SS, SC, S-beta-thalassemia or other hemoglobinopathies causing sickle cell disease is required).
• Acute onset pain crisis in a distribution typical for that subject, onset within the last 7 days and for which hospitalization and parenteral narcotic pain treatment are required.
• Ability to provide informed written consent.

You may not qualify if:

• Pregnancy.
• History of non-trivial injury, burns, surgery or skin ulcers on the arms.
• Fever or suspected sepsis at time of pain crisis
• Administration of any of the following drugs within the last 14 days:
• Phosphodiesterase-5 inhibitors (sildenafil, vardenafil, tadalafil)
• Endothelin-1 receptor blockers (bosentan, sitaxentan, ambrisentan, tezosentan)
• Nitric oxide donors (nitroglycerin, nitroprusside, nitrates)
• Ingestion of caffeine within the 12 hours before the start of the study appointment, or tobacco use within the 30 days before the study appointment.
• Diagnosis with any of the following chronic diseases or conditions:
• History of high blood pressure
• History of high cholesterol
• History of diabetes
• History of chronic kidney disease (serum creatinine must not be greater than 2 mg/dL)
• History of coronary artery disease or peripheral vascular disease
• Received a blood transfusion within 7 days of the study procedure.

Sponsors & Collaborators

• Children's National Research Institute: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

Children's National Medical Center

Washington D.C., District of Columbia, 20010, United States

Location

MeSH Terms

Conditions

Anemia, Sickle Cell

Interventions

Spectroscopy, Near-Infrared

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

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Hematology

Study Record Dates

• First Submitted: July 22, 2019
• First Posted: July 24, 2019
• Study Start: June 26, 2019
• Primary Completion: September 3, 2023
• Study Completion: September 3, 2023
• Last Updated: September 14, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)