New Non-Invasive Blood Pressure (NIBP) Enhancement for Neonates and Children

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The trial collects clinical data to validate the accuracy of NIBP measurement algorithms on the NIBP Standard Parameter Module following IEC 80601-2-30:2018 and ISO 81060-2:2018+AMD2:2024. It is an interventional study focusing on automated intermittent NIBP measurements in pediatric populations. Participants are admitted pediatric patients or neonates with an arterial line as part of standard care and who fit specific cuff sizes. Data will be gathered in a hospital setting to compare the enhanced NIBP measurements against invasive blood pressure readings. The study aims to support regulatory-grade validation for safer, easier blood pressure monitoring in children.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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's running

• Helsinki University Hospital
  Helsinki, Finland Recruiting
• Helsinki University Hospital
  Helsinki, Finland Recruiting

Study contacts

• Study coordinator: Otto Rahkonen Principal Invastigator
• Email: otto.rahkonen@hus.fi
• Phone: +35894711

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Automated Non-Invasive Blood Pressure: Tracking Blood Pressure Changes Using SpO2 Data

  This study tests an algorithm that estimates blood pressure changes using data from an SpO2 sensor in patients in the OR, PACU, or ICU who already have invasive BP measured as part of standard care.

  Recruiting GE Healthcare · Helsinki and 1 other locations · NCT07790458

• NIBP Accuracy Validation in Adults

  This study tests how accurately a non-invasive blood pressure device measures blood pressure in adults by comparing it with arterial line readings.

  Recruiting GE Healthcare · Helsinki · NCT07697950

• Non-invasive blood pressure accuracy study for adults

  This study tests whether non-invasive blood pressure readings match invasive aortic pressure measurements in adults who need arterial line monitoring.

  Recruiting GE Healthcare · Tampere · NCT07628296

• Inflation-based non-invasive blood pressure test compared with standard cuff method

  This study tests whether the Philips iNIBP device gives BP readings that match the usual auscultatory cuff method in people aged 3 to 85.

  Recruiting Philips Clinical & Medical Affairs Global · Louisville, Colorado · NCT07901608

• Overnight Temperature Regulation to Test Gut Health, Inflammation, and Circadian Rhythms

  This study tests whether two weeks of using the Eight Sleep Pod at night can improve gut bacteria balance, lower inflammation, and strengthen daily temperature and blood pressure rhythms in postmenopausal women and age-matched men with poor sleep.

  Recruiting Eight Sleep Inc. · Newton Center, Massachusetts · NCT07848594

• Blood Pressure from Face Video (Vitacam)

  A contactless vitals tool called Vitacam tests if video-based blood pressure readings from the face can match standard cuff measurements in adults.

  Recruiting Evondos Oy · Tampere · NCT07739667

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.