Abdomen-based pulse oximeter for babies with congenital heart disease
Official title: PRISM: PRecision Integrated Saturation Monitor A Novel Approach to Monitoring Oxygen Saturation in Children A Prospective, Observational, Comparative Validation Clinical Study to Evaluate the Accuracy of a Novel Abdominal Pulse Oximeter With Integrated Motion Detection and Skin Tone Calibration Against Arterial Blood Gas (SaO₂) Measurements and Conventional Fingertip Pulse Oximetry (SpO₂) in Pediatric Patients.
Run by Le Bonheur Children's Hospital · NCT07686341 · Data updated 2026-11-12
This study tests whether a belly-worn pulse oximeter works as well as a traditional fingertip device in babies with complex heart conditions.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 0 Months to 12 Months |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Le Bonheur Children's Hospital Academic / other |
| Locations | 1 site (Memphis, Tennessee) |
| Status | Recruiting |
| Started | August 2026 |
| Main results expected | August 2028 |
| Study ends | December 2028 |
| Registry record updated | July 7, 2026 |
| Trial ID | NCT07686341 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Infants aged 0-12 months who are admitted to the ICU, have an arterial line as standard of care (when applicable), weigh over 2 kg, and whose parent/guardian provides informed consent.
✕Probably not a fit
Some infants may not experience improved readings and standard monitoring will continue to be used clinically.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study compares an abdomen-worn pulse oximeter prototype to standard fingertip sensors in infants with congenital heart disease. Data will be collected from medical records during a 3-day hospital stay, with no extra visits. The abdomen device aims to reduce motion-related reading errors by monitoring at a lower-motion site and using motion detection. The approach builds on prior work with abdomen-based monitoring for other signals and integrates a pediatric-friendly sensor housing. The study is conducted at Le Bonheur Children's Hospital in collaboration with CTIP under IRB approval.
Why it matters
Potential benefit: If successful, the abdomen-based sensor could provide more accurate, reliable oxygen readings for infants in the hospital, potentially improving clinical decisions and safety.
How similar studies have gone: Prior development of abdomen-based monitoring for ECG and promising feasibility data support exploring its use for pulse oximetry.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 0-12 months of age. (Must be less than 1 year of life for the pulse oximeter portion of the study) Weight greater than 2 Kg at time of study * Admitted to an intensive care unit. (Not applicable for outpatient cohort) * Arterial line in place as standard of care (Not applicable for outpatient cohort) * Informed consent provided by parent or LAR. Exclusion Criteria: * Open Sternum * Skin abnormalities at the proposed sensor site (e.g., rash, eczema, wounds, stoma, or infection) * Known allergy or sensitivity to adhesives or materials used in the sensor * Excessive movement or irritability that precludes safe and effective placement of the sensor * Parent or legal guardian unable to provide informed consent
Where it's running
-
Le Bonheur Children's Hospital
Memphis, Tennessee, United States Recruiting
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Ultrafast ultrasound imaging for congenital heart disease in children
This project will try ultrafast ultrasound to measure heart muscle stiffness and blood flow in children with congenital heart disease.
-
Bilateral superficial parasternal intercostal plane block vs erector spinae plane block for heart surgery
In children with congenital heart disease, this study tests whether two ultrasound-guided nerve blocks used with fentanyl can better control pain after heart surgery than the other block.
-
Dapagliflozin treatment for adults with failing Fontan circulation
This study is testing if dapagliflozin, a diabetes medication, can help adults with heart failure after the Fontan procedure feel better by looking at changes in their heart pressure during rest and exercise.
-
Evaluating udenafil for adolescents after Fontan procedure
This study is testing if a new medication called udenafil can help teenagers who have had heart surgery feel better and exercise more easily.
-
Using nitric oxide during heart surgery in newborns to prevent kidney injury
This study is testing if using nitric oxide during heart surgery can help newborns avoid kidney injury after their operation.
-
Improving transition of congenital heart disease care from pediatric to adult services
This program will try a multi-step transfer process to reduce health declines in people with congenital heart disease who are waiting to see an adult specialist.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.