Observational Data Collection for Blood Hemoglobin Algorithm Validation in Pediatrics

Starting soon

Conditions studied: Hemoglobin, Cerebral Oxygenation, Congenital Heart Disease

In brief

This study will enroll children and young adults who are scheduled to undergo planned heart surgery or a heart catheterization procedure while under general anesthesia. Researchers will collect information from a forehead sensor that measures oxygen levels in the body's tissues, along with blood hemoglobin measurements obtained from blood samples that are already being collected as part of routine medical care. The goal of the study is to determine whether a blood hemoglobin monitoring method that has already been cleared by the U.S. Food and Drug Administration (FDA) for use in adults may also work well in pediatric patients.

Key facts

Study ID

NCT07706140

Run by

Boston Children's Hospital

People needed

100

Starts

2026-08-01

Expected to finish

2027-12-01

Last updated by the study team

2026-07-27

Who can join

Age: any, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age less than 21 years at the time of enrollment.
• Scheduled for elective cardiac surgery or elective cardiac catheterization under general anesthesia.
• Placement of an arterial catheter as part of routine clinical care for the procedure.

You may not qualify if…

• Presence of skin, scalp, or craniofacial abnormalities that prevent proper placement of the near-infrared spectroscopy (NIRS) sensor or may significantly affect measurement quality.
• Inability to obtain arterial blood hemoglobin measurements using standard clinical methods.

Where it is running

• Boston Children's Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.