NIBP Study for Neonate and Pediatric Subject Populations

NCT07684885 | Recruiting

• 1 other identifier: SA-000054
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is developing new NIBP enhancement and test it in clinical environment with neonates and children population subjects.

Conditions

Blood Pressure Measurement; Blood Pressure

Outcome Measures

Primary Outcomes (1)

• Primary Outcome Measure

  Collection of non-invasive blood pressure measurements data from subjects in clinical setting.

  Up to 12 hours from time of study procedure start

Other Outcomes (1)

• Safety Outcome

  6 months

Study Arms (2)

Child Cuff vs Small Adult Cuff (Upper arm overlap, 17-19 cm)

ACTIVE COMPARATOR

Subjects with an upper-arm circumference within 17-19 cm, where both Child Cuff and small adult cuffs are suitable, are randomized in a 1:1 ratio to receive blood pressure measurements using either: Child Cuff or Small Adult cuff Subjects with upper-arm circumferences in non-overlapping small adult -only ranges are assigned the Small Adult cuff without randomization and are not included in this arm.

Device: NIBP Measurement

Small Adult vs Adult Cuff (Upper arm overlap, 23-25cm)

ACTIVE COMPARATOR

Subjects with an upper-arm circumference within 23-25 cm, where both Small Adult (SA) and Adult (A) cuffs are suitable, are randomized in a 1:1 ratio to receive blood pressure measurements using either: -Small Adult cuff, or -Adult cuff Subjects with upper-arm circumferences in non-overlapping SA-only ranges are assigned the Small Adult cuff without randomization and are not included in this arm.

Device: NIBP Measurement

Interventions

NIBP Measurement DEVICE

The collection of non-invasive blood pressure measurements using NIBP Standard Parameter Module with SuperSTAT algorithm with simultaneous invasive blood pressure waveform recordings per discretion of the sponsor upon combining the data from other clinical studies to comply with ISO 81060-2:2018 +AMD2:2024.

Child Cuff vs Small Adult Cuff (Upper arm overlap, 17-19 cm); Small Adult vs Adult Cuff (Upper arm overlap, 23-25cm)

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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

Sponsors & Collaborators

• GE Healthcare: lead

Study Sites (2)

Helsinki University Hospital

Helsinki, 00290, Finland

RECRUITING

Helsinki University Hospital

Helsinki, 00290, Finland

RECRUITING

Central Study Contacts

Otto Rahkonen Principal Invastigator

CONTACT

+35894711; otto.rahkonen@hus.fi

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2025
• First Posted: July 6, 2026
• Study Start: May 14, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 6, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

FI (2)