Observational Data Collection for Blood Hemoglobin Algorithm Validation in Pediatrics
Key facts
- Who runs it
- Boston Children's Hospital
- Where
- Boston, United StatesSee the site
- Trial code
- Status
- Not yet recruiting
- People taking part
- 100 people, planned
- Started
- Aug 2026
- Expected to end
- Dec 2027
- Type of study
- Observational
- Treatments tested
- Noninvasive hemoglobin monitoring
- Record updated
- 27 July 2026
Who can take part
- Age
- 0 days to 21 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
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Who can take part
- 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
Who cannot take part
- Inability to obtain arterial blood hemoglobin measurements using standard clinical methods
- Presence of skin, scalp, or craniofacial abnormalities that prevent proper placement of the near-infrared spectroscopy (NIRS) sensor or may significantly affect measurement quality
Where in United States
- Boston Children's HospitalBoston, United StatesContact: Rachel Bernier, MPHNo longer taking part
About the trial
What the trial wants to find out
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.
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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.
The group in the trial
- Pediatric Cardiac Surgery and Pediatric Catheterization Patients
This cohort includes pediatric patients undergoing elective cardiac surgery or elective cardiac catheterization under general anesthesia. All participants receive standard clinical care, including routine physiologic monitoring and arterial blood sampling when clinically indicated. As part of routine monitoring, a FDA-cleared near-infrared spectroscopy (NIRS)-based tissue oximetry system (ForeSight Tissue Oximetry System) will be placed on the forehead to continuously record cerebral tissue oxygenation during the procedure. Arterial blood samples obtained for clinical care will be analyzed using standard blood-gas/co-oximetry methods to measure blood hemoglobin levels. In select cases, a small number of additional blood samples may be collected to support data analysis. This is an observational study only. No investigational devices are used, no interventions are assigned, and there is no change to clinical management. All collected data are de-identified prior to analysis.
Treatment: Noninvasive hemoglobin monitoring
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Prospective Observational Data Collection Study for Validation of a Near-Infrared Spectroscopy-Based Blood Hemoglobin Algorithm in Pediatric Patients Undergoing Cardiac Surgery or Cardiac Catheterization
- Record updated
- 27 July 2026