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Tiny trial of infant blood pressure cuff ends early

NCT ID NCT05976425

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a new blood pressure device called ModPG3 on 7 newborns and infants to see if it meets international accuracy standards. The device uses two methods to measure blood pressure during cuff inflation and deflation. The trial was terminated early, so results are limited.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ModPG3 blood pressure device

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

7 people

The number who actually took part.

Started

Feb 2024

Finished

Apr 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Up to 3 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

1. 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. 2. 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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • East Carolina University

    Greenville, North Carolina, 27834, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.