Blood PressureNCT05976425

ModPG3 Neo-Infant ISO 81060-2:2018

A study testing ModPG3 Investigational Device and Invasive Reference Equipment in people with Blood Pressure, run by Welch Allyn at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Automated blood pressure cuff measurements taken by an "oscillometric device" is the standard in numerous medical settings today. Studies show that oscillometric devices using algorithms are more accurate and consistent than devices using other non-invasive measuring techniques, especially in critical cases. Read more about this study

Who is it for?: Ages Up to 3 yearsHealthy volunteers can take part
Conditions the study is for: Blood Pressure
What is being tested?: ModPG3 Investigational Device and Invasive Reference Equipment
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 7 participants
Where: 1 siteUnited States
Study dates: 23 Feb 2024to 29 Apr 2025
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 3 years
All sexes
Healthy volunteers accepted
Child

Inclusion Criteria

Meets the neonatal or infant (less than 3 years of age) subject population.
The neonate and infant subjects will already have an indwelling intra-arterial line.
Subject's legally authorized representative must consent for the subject to participate.
Subject's legally authorized representative must be able to read, write, speak in English and/or Italian.
Subject must have an arm circumference in the range of 3.3-15.0 cm.
Subject must be able to have blood pressures taken on the upper extremity closest to the arterial line
The subject has one upper arm that is free of indwelling catheters or IV lines, shunts, oximetry sensors, dressings, etc. for attachment of a NIBP cuff.

Exclusion Criteria

Lack of Informed consent.
Subjects with deformities or abnormalities that may prevent proper application of the device under test.
Subject is evaluated by the investigator or clinician and found to be medically unsuitable for participation in this study.
Subjects with known heart dysrhythmias or arrhythmias during the measurement period.
Subjects with compromised circulation or peripheral vascular disease.
Subjects who have had surgery or have shunts or implants in the upper extremity being tested.
Those who have a heart rate that is irregular for any reason other than normal fluctuations in the R-to-R interval associated with respiration.
Hospital System Pre-Screening NIBP: those who have a systolic and/or diastolic blood pressures difference > 12 mmHg between the hospital intra-arterial measurement and the hospital blood pressure cuff/automated vital signs monitor are excluded. The device under test cannot be used for this reading.
Subjects with clotting disorders or taking prescribed blood thinners.
Subjects with a severe contact allergy to sensors or cuff material.
Subjects with a history of skin fragility or breakdown, such as ecchymosis or lacerations, affecting the upper extremities that would affect the application of NIBP cuff.
Subjects whose arm circumference does not fall within 3.3 and 15.0 cm.
Arterial line is not properly damped.
The subject has an unstable condition in which NIBP cannot be obtained.
Subjects who have radial or brachial arterial lines.
Subjects who require sedation solely for the purpose of this study and/or prolonged sedation from a prior procedure.

Trial locations and contacts

1 site in 1 country.

United States1 site

East Carolina University
Greenville, North Carolina, 27834

Other trials in United States

About this study

Official title: ModPG3 Blood Pressure Device for Neo-Infants

Automated blood pressure cuff measurements taken by an "oscillometric device" is the standard in numerous medical settings today.

Studies show that oscillometric devices using algorithms are more accurate and consistent than devices using other non-invasive measuring techniques, especially in critical cases.

SureBP algorithm estimates BP during cuff inflation; the second, StepBP algorithm does so during deflation.

The purpose of this study is to test the algorithms contained in the ModPG3 on Neonate and Infants subjects to determine if they meet the requirements of ISO 81060-2:2018/Amd 1:2020 Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type

Conditions: Blood Pressure
Being tested: ModPG3 Investigational Device, Invasive Reference Equipment

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ModPG3 Investigational DeviceDevice
- Connex Vital Sign Monitor with ModPG3
- Laptop
- Data Collection Software
- USB cable
- Power strip
- Welch Allyn FlexiPort Disposable Blood Pressure Cuffs
Invasive Reference EquipmentDevice
- Surveyor S12/S19
- Hill-Rom ICU Medical data collection cable DIR 60119852
- Hill-Rom Edwards data collection cable DIR 60119853

Study groups in NCT05976425
Study group	Role	What they receive
Blood Pressure Readings	Experimental	Using the data acquisition software provided, a reading for the subject will be started. The tool will automatically record the pre-invasive blood pressure readings, then take the NIBP measurement with the device under test, and it will follow up with a post invasive blood pressure reading. Receives: Device: ModPG3 Investigational Device; Device: Invasive Reference Equipment

What is being measured

The primary outcome is the main question the study is designed to answer.

Compliance of the ModPG3 Blood Pressure (BP) Readings With ISO Requirements
Data shall be analyzed according to the formulas called out in section 6.2.6 of ISO 81060-2:2018/Amd 1:2020.
Measured: Day 1 (up to one hour)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 Feb 202429 Apr 2025

First posted4 Aug 2023
Study start23 Feb 2024
Primary completion29 Apr 2025
Study completion29 Apr 2025

Why it stopped: This study was terminated early due to insufficient data collection.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Blood PressureStudies of the same condition, open and under way.
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
Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 7 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05976425
Sponsor's protocol ID: 60106449
Status last verified: Feb 2026
First submitted: 28 Jul 2023
Last updated: 23 Feb 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: Sharing of Clinical Trial Data: Baxter is committed to sharing clinical trial data with external medical experts and scientific researchers in the interest of advancing public health. As such, Baxter will supply anonymized Individual Patient Datasets (IPD) and supporting documents (synopsis of clinical study reports, protocol and SAP's)

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: ModPG3 Blood Pressure Device for Neo-Infants
ClinicalTrials.gov ID: NCT05976425
Acronym / sponsor ID: 60106449
Conditions: Blood Pressure
Study type: Interventional
Recruitment status: TerminatedReason stopped: This study was terminated early due to insufficient data collection.
Enrolment: 7 participants (actual)
Lead sponsor: Welch AllynIndustry (pharma, biotech, devices)
Study start: 23 Feb 2024 (actual)
Primary completion: 29 Apr 2025 (actual)
Study completion: 29 Apr 2025 (actual)
First posted: 4 Aug 2023 (actual)
Results: Posted 23 Feb 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Automated blood pressure cuff measurements taken by an "oscillometric device" is the standard in numerous medical settings today.

Studies show that oscillometric devices using algorithms are more accurate and consistent than devices using other non-invasive measuring techniques, especially in critical cases.

SureBP algorithm estimates BP during cuff inflation; the second, StepBP algorithm does so during deflation.

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Blood Pressure Readings	Experimental	Device: ModPG3 Investigational Device, Device: Invasive Reference EquipmentUsing the data acquisition software provided, a reading for the subject will be started. The tool will automatically record the pre-invasive blood pressure readings, then take the NIBP measurement with the device under test, and it will follow up with a post invasive blood pressure reading.

Who may qualify

Ages: Up to 3 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

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
ModPG3 Investigational Device* Connex Vital Sign Monitor with ModPG3 * Laptop * Data Collection Software * USB cable * Power strip * Welch Allyn FlexiPort Disposable Blood Pressure Cuffs	Device	Blood Pressure Readings
Invasive Reference Equipment* Surveyor S12/S19 * Hill-Rom ICU Medical data collection cable DIR 60119852 * Hill-Rom Edwards data collection cable DIR 60119853	Device	Blood Pressure Readings

Primary outcome

Compliance of the ModPG3 Blood Pressure (BP) Readings With ISO Requirements
Time frame: Day 1 (up to one hour)
Data shall be analyzed according to the formulas called out in section 6.2.6 of ISO 81060-2:2018/Amd 1:2020.

Results and safety

Results posted to the registry on 23 Feb 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Enrolled Subjects	7	2

Primary outcome: Compliance of the ModPG3 Blood Pressure (BP) Readings With ISO Requirements

Time frame: Day 1 (up to one hour)

Population analysed: The study was terminated due to errors in the algorithm planned for data processing and analysis. A validated post-processing algorithm for the raw data files was never finalized; therefore, no analyzable blood pressure measurements exist and no participants were analyzed. No future analysis is planned, and no outcome data will ever be available for this study.

Adverse events

Time frame: Baseline to approximately 1 hour after consent; no follow-up was required.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Blood Pressure Readings	0 of 7 (0%)	0 of 7 (0%)	0 of 7

Limitations and caveats (from the sponsor): The study was terminated early due to errors in the StepBP and SureBP algorithms. Although raw data files were captured, no validated post processing algorithm was finalized; therefore, no analyzable blood pressure measurements exist. As a result, no outcome data are reported and no participants were analyzed.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. Sharing of Clinical Trial Data: Baxter is committed to sharing clinical trial data with external medical experts and scientific researchers in the interest of advancing public health. As such, Baxter will supply anonymized Individual Patient Datasets (IPD) and supporting documents (synopsis of clinical study reports, protocol and SAP's)

Related trials for Blood Pressure

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Not yet recruiting
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Recruiting
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Recruiting
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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. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing ModPG3 Investigational Device and Invasive Reference Equipment in people with Blood Pressure, run by Welch Allyn at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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: stopped early, as of the sponsor's last update on 23 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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?

Yes. Results are posted in the registry (first posted 23 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Compliance of the ModPG3 Blood Pressure (BP) Readings With ISO Requirements (time frame: Day 1 (up to one hour)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05976425.

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 23 Feb 2026.