Automated Device for High Blood Pressure in Infants
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify whether participants need to stop taking their current medications.
What data supports the effectiveness of the treatment ModPG3, ModPG3 Neo-Infant ISO 81060, Welch Allyn ModPG3 for high blood pressure in infants?
Research shows that automatic blood pressure monitors using the oscillometric method are accurate and safe for infants, with high correlation to other measurement methods. This suggests that similar devices, like the ones in the trial, could effectively monitor and manage high blood pressure in infants.12345
Is the automated device for high blood pressure in infants safe for use?
How does the ModPG3 treatment for high blood pressure in infants differ from other treatments?
The ModPG3 treatment is unique because it uses an automated, noninvasive device to measure blood pressure in infants, making it safer and easier compared to traditional methods that might require invasive procedures. This device is specifically designed for infants, providing accurate and reliable blood pressure readings without causing discomfort or requiring complex setups.12489
What is the purpose of this trial?
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
Eligibility Criteria
This trial is for neonates and infants under 3 years old with high blood pressure who have an arterial line in place. They must have one arm free of medical devices for cuff attachment, an arm circumference of 3.3-15.0 cm, and a legal representative who consents to participation and understands English or Italian.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo blood pressure measurements using the ModPG3 device to test SureBP and StepBP algorithms
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- ModPG3
ModPG3 is already approved in United States, European Union for the following indications:
- Blood pressure measurement in neonates and infants
- Blood pressure measurement in neonates and infants
Find a Clinic Near You
Who Is Running the Clinical Trial?
Baxter Healthcare Corporation
Lead Sponsor
Dr. Heather Knight
Baxter Healthcare Corporation
Chief Medical Officer
MD
Brent Shafer
Baxter Healthcare Corporation
Chief Executive Officer
Bachelor's degree in Business Administration