Tiny trial of infant blood pressure cuff ends early
NCT ID NCT05976425
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
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7 people
The number who actually took part.
- Started
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Feb 2024
- Finished
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Apr 2025
- Lead sponsor
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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
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Up to 3 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide 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
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East Carolina University
Greenville, North Carolina, 27834, United States
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