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Forehead sensor to estimate blood hemoglobin in children with congenital heart disease

Checks a forehead sensor's hemoglobin readings in children having heart surgery or catheterization.

Key facts

Who runs it
Boston Children's Hospital
Where
Boston, United StatesSee the site
Trial code
Registry title
Observational Data Collection for Blood Hemoglobin Algorithm Validation in Pediatrics
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

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for children and young adults who have planned heart surgery or a heart catheter procedure under general anesthesia. It tests whether a forehead sensor can measure blood hemoglobin in children.

Age
From birth (0 days) to less than 21 years
Sex
All sexes
Disease stage
Planned (elective) heart surgery or heart catheterization under general anesthesia. The conditions studied include congenital heart disease.

Main reasons for not taking part

  • Skin, scalp, or face and skull problems that stop the forehead sensor from being placed or working well
  • Arterial blood hemoglobin cannot be measured with standard methods
  • No artery line (arterial catheter) placed as part of routine care for the procedure

The registry criteria, word for word

Show all 5 criteriaShow less

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, MPHNot yet recruiting

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.

Read full original descriptionShow less

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

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

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Data 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
Plain-language title
Forehead sensor to estimate blood hemoglobin in children with congenital heart diseaseGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Record updated
27 July 2026