Blood PressureNCT07684885
NIBP Study for Neonate and Pediatric Subject Populations
A study testing NIBP Measurement in people with Blood Pressure and Blood Pressure Measurement, run by GE Healthcare at 2 sites in Finland.
Trial summary
The purpose of this study is developing new NIBP enhancement and test it in clinical environment with neonates and children population subjects. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Blood Pressure, Blood Pressure Measurement
- What is being tested?
- NIBP Measurement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 2 sitesFinland
- Study dates
- 14 May 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Finland2 sites, 2 recruiting
- Recruiting
Helsinki University Hospital
Helsinki, 00290
Otto Rahkonen Principal Investigator, +35894711, otto.rahkonen@hus.fi
- Recruiting
Helsinki University Hospital
Helsinki, 00290
Otto Rahkonen Principal Investigator, +358094711, otto.rahkonen@hus.fi
About this study
Official title: Non-Invasive Blood Pressure Accuracy Study for Neonate and Pediatric Subject Populations
The purpose of this study is developing new NIBP enhancement and test it in clinical environment with neonates and children population subjects.
Read the detailed description
The purpose of the study is to collect clinical data for validation of the accuracy of non-invasive blood pressure (NIBP) measurement algorithms on the Non-invasive Blood Pressure (NIBP) Standard Parameter Module (SPM) per IEC 80601-2-30:2018, Medical electrical equipment-Part 2-30: Particular requirements for basic safety and essential performance of automated non-invasive sphygmomanometers standard, section 201.106. In addition, the study will be conducted per ISO 81060-2:2018+AMD2:2024 Non-invasive sphygmomanometers-Part 2: Clinical investigation of intermittent automated measurement type.
- Conditions
- Blood Pressure, Blood Pressure Measurement
- Being tested
- NIBP Measurement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NIBP MeasurementDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: NIBP Measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome Measure
Collection of non-invasive blood pressure measurements data from subjects in clinical setting.
Measured: Up to 12 hours from time of study procedure start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study start14 May 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood PressureStudies of the same condition, open and under way.
- More trials run by GE HealthcareThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GE Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07684885
- Sponsor's protocol ID
- SA-000054
- Status last verified
- Jun 2026
- First submitted
- 31 Mar 2025
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Invasive Blood Pressure Accuracy Study for Neonate and Pediatric Subject Populations
- ClinicalTrials.gov ID
- NCT07684885
- Acronym / sponsor ID
- SA-000054
- Conditions
- Blood Pressure, Blood Pressure Measurement
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- GE HealthcareIndustry (pharma, biotech, devices)
- Study start
- 14 May 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 6 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is developing new NIBP enhancement and test it in clinical environment with neonates and children population subjects.
Detailed description
The purpose of the study is to collect clinical data for validation of the accuracy of non-invasive blood pressure (NIBP) measurement algorithms on the Non-invasive Blood Pressure (NIBP) Standard Parameter Module (SPM) per IEC 80601-2-30:2018, Medical electrical equipment-Part 2-30: Particular requirements for basic safety and essential performance of automated non-invasive sphygmomanometers standard, section 201.106. In addition, the study will be conducted per ISO 81060-2:2018+AMD2:2024 Non-invasive sphygmomanometers-Part 2: Clinical investigation of intermittent automated measurement type.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Child Cuff vs Small Adult Cuff (Upper arm overlap, 17-19 cm) | Active comparator | Device: NIBP MeasurementSubjects 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. |
| Small Adult vs Adult Cuff (Upper arm overlap, 23-25cm) | Active comparator | Device: NIBP MeasurementSubjects 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. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NIBP MeasurementThe 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. | Device | Child Cuff vs Small Adult Cuff (Upper arm overlap, 17-19 cm), Small Adult vs Adult Cuff (Upper arm overlap, 23-25cm) |
Primary outcome
Primary Outcome Measure
Time frame: Up to 12 hours from time of study procedure start
Collection of non-invasive blood pressure measurements data from subjects in clinical setting.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NIBP Measurement in people with Blood Pressure and Blood Pressure Measurement, run by GE Healthcare at 2 sites in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Otto Rahkonen Principal Invastigator (+35894711, otto.rahkonen@hus.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Outcome Measure (time frame: Up to 12 hours from time of study procedure start). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.