NIBP Study for Neonate and Pediatric Subject Populations
Recruiting now · Not applicable
Conditions studied: Blood Pressure, Blood Pressure Measurement
In brief
The purpose of this study is developing new NIBP enhancement and test it in clinical environment with neonates and children population subjects.
Key facts
- Study ID
- NCT07684885
- Run by
- GE Healthcare
- People needed
- 110
- Starts
- 2025-05-14
- Expected to finish
- 2026-12-31
- Last updated by the study team
- 2026-07-06
Who can join
Age: any, up to 18. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age requirement: 0 to < 18 years.
- For children under 15 years old: Has a guardian or other legal representative who is able to provide consent of a guardian OR
- For children between the age of 15-17 years; able to provide written consent form and the legal guardians can be reached to be informed of the study participation.
- Have an upper limb (right OR left side) that fits the cuff size of the device (circumference ranging 3 cm to 33 cm) OR have a thigh (right OR left side) that fits a cuff size of the device (circumference ranging 38 to 50 cm).
- Have an arterial line as a standard of care, which measures invasive blood pressure.
- Expected to remain in the unit for the duration of the study procedure.
You may not qualify if…
- Have previously participated in this study (no subject may participate more than once).
- Subjects with peripheral arterial diseases (causing left/right arm difference).
- Hemodynamically unstable subjects Subjects with complications on vasoactive agents at discretion of the Investigator.
- Exhibited injuries, deformities, intravenous lines, or other abnormalities that, in the opinion of the Investigator, may prevent proper cuff application or functioning.
- Are suffering from infection(s) or immunocompromised subjects that require isolation.
- For adolescents of child-bearing potential, who are currently pregnant, suspected to be pregnant, or are currently lactating.
- PI, designee or caring physician decision due to subject health conditions
Where it is running
- Helsinki University Hospital — Helsinki, Finland (enrolling)
- Helsinki University Hospital — Helsinki, Finland (enrolling)
Full record on ClinicalTrials.gov
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