NCT04031521

Near Infrared Spectroscopy in Sickle Cell Pediatric Patients

Near-infrared Spectroscopy in Sickle Cell Pediatric Patients During Pain Crisis and After Recovery

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: Children's National Research Institute · Academic / Other
• Sex: All
• Age: 6 Years – 21 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Near infrared spectroscopy	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.

Timeline

• Start date: 2019-06-26
• Primary completion: 2023-09-03
• Completion: 2023-09-03
• First posted: 2019-07-24
• Last updated: 2023-09-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study