Automated Device for High Blood Pressure in Infants

Not currently recruiting at 2 trial locations

Overseen By Baxter Clinical Trials Disclosure Call Center

Age: Any Age

Sex:

Trial Phase: Academic

Sponsor: Baxter Healthcare Corporation

Disqualifiers: Heart dysrhythmias, Peripheral vascular disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new device called ModPG3, which measures blood pressure in babies. It uses two algorithms to check blood pressure during different stages of the cuff's inflation and deflation. The goal is to determine if this new method meets international standards for accuracy and reliability. Babies with an intra-arterial line who can have a blood pressure cuff placed on their arm are suitable candidates for this study. As an unphased trial, this study allows participants to contribute to innovative research that could enhance future healthcare for infants.

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 prior data suggests that this device is safe for infants?

Research shows that the ModPG3 device is safe and accurate for measuring blood pressure in infants. Studies have not found any major issues with its use. The device uses two methods, SureBP and StepBP, to estimate blood pressure. SureBP operates during cuff inflation, while StepBP functions during deflation. Both methods prove more accurate and reliable than other non-invasive techniques, especially in critical situations.

These results are promising, as the device undergoes testing to meet international safety standards, ensuring high safety and effectiveness. Overall, previous studies report that the ModPG3 is a well-tolerated tool for infants, with no major safety concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it tests a new device, ModPG3, designed to automate blood pressure monitoring in infants. Unlike traditional methods that often require manual measurement and can be invasive, ModPG3 offers a non-invasive approach that automatically records blood pressure readings before, during, and after testing. This innovative method has the potential to improve accuracy and comfort in monitoring high blood pressure in infants, which is crucial for early and effective intervention.

What evidence suggests that this device is effective for high blood pressure in infants?

Studies have shown that devices using oscillometric technology, which rely on mathematical formulas to measure blood pressure, offer greater accuracy and consistency than other non-invasive methods, especially in critical situations. In this trial, participants will use the ModPG3 device, which employs two formulas, SureBP and StepBP, to measure blood pressure as the cuff inflates and deflates. Research indicates that these formulas accurately measure systolic blood pressure (the pressure in arteries when the heart beats) in infants, showing a strong match with traditional methods. This suggests that ModPG3 could effectively provide reliable blood pressure readings for infants and newborns. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

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

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

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo blood pressure measurements using the ModPG3 device to test SureBP and StepBP algorithms

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• ModPG3

Trial Overview The study tests the accuracy of two algorithms within the ModPG3 device against ISO standards for non-invasive blood pressure measurements in young patients: SureBP measures during inflation, while StepBP measures during deflation.

How Is the Trial Designed?

Group I: Blood pressure readings Experimental Treatment 2 Interventions

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.

ModPG3 is already approved in United States, European Union for the following indications:

Approved in United States as ModPG3 for:

• Blood pressure measurement in neonates and infants

Approved in European Union as ModPG3 for:

• Blood pressure measurement in neonates and infants

Who Is Running the Clinical Trial?

Baxter Healthcare Corporation

Lead Sponsor

Trials

328

Recruited

203,000+

Dr. Heather Knight

Baxter Healthcare Corporation

Chief Medical Officer

MD

Brent Shafer

Baxter Healthcare Corporation

Chief Executive Officer

Bachelor's degree in Business Administration

Published Research Related to This Trial

Accurate blood pressure measurement is crucial for diagnosing hypertension, especially in children and adolescents, as misdiagnosis can lead to long-term negative consequences.

Automated blood pressure measurement, particularly 24-hour ambulatory blood pressure measurement (ABPM), significantly reduces observer errors and provides valuable data for diagnosing hypertension in children, including insights into various health conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Utility of ambulatory blood pressure monitoring in children and adolescents. Graves, JW., Althaf, MM.[2018]

The new indirect automatic blood pressure monitor for infants demonstrated high accuracy in measuring systolic blood pressure, with correlation coefficients ranging from 0.82 to 0.94 across different age groups, including premature and term neonates as well as older infants.

The device was found to be safe and effective, with no significant technical issues reported, making it a reliable noninvasive option for monitoring blood pressure in infants during general anesthesia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Indirect measurement of blood pressure in neonates and infants utilizing an automatic noninvasive oscillometric monitor. Friesen, RH., Lichtor, JL.[2004]

The CAS model 9010 oscillometric blood pressure monitor was validated in two studies, one involving 88 participants aged 4 to 78 years and another with 35 newborns, demonstrating its accuracy across a wide age range.

The monitor met all Association for the Advancement of Medical Instrumentation (AAMI) standards, confirming its safety and efficacy for use in both children and adults, including premature infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validation of CAS model 9010 automated blood pressure monitor:children/adult and neonatal studies. Alpert, BC.[2019]

The American Academy of Pediatrics has updated its guidelines on childhood hypertension, reflecting new findings and including revised normative data and blood pressure classifications.

The updated guidelines strongly recommend the use of ambulatory blood pressure measurement and have lowered the target blood pressure levels for hypertensive children, both with and without chronic kidney disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

American Academy of Pediatrics Clinical Practice Guidelines for Screening and Management of High Blood Pressure in Children and Adolescents: What is New? Sinha, R., Saha, A., Samuels, J.[2019]

The Omron 705-CP blood pressure monitor was validated in a study involving 60 adolescents, showing high accuracy with 97.9% of systolic and 98.8% of diastolic measurements differing by 15 mmHg or less from a standard mercury sphygmomanometer.

The device demonstrated excellent performance, with 86.3% of systolic and 90.4% of diastolic measurements differing by 10 mmHg or less, classifying it as grade A for accuracy, making it a reliable tool for blood pressure monitoring in this age group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Evaluation of the Omron 705-CP blood pressure measuring device for use in adolescents and young adults]. Furusawa, EA., Ruiz, MF., Saito, MI., et al.[2019]

The study involved 43 children with diabetes and evaluated the use of an electronic blood pressure monitor, which was found to be simple, reliable, and met accuracy standards set by professional organizations.

Out of the participants, 38 children successfully measured their own blood pressure at home and were able to teach family members, indicating that home monitoring can be a valuable tool in managing blood pressure in diabetic children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home blood pressure monitoring in diabetes. Gompels, C., Savage, D.[2019]

The study validated three blood pressure monitors in 132 children aged 5-15 years, finding that the Datascope Accutorr Plus was the only device to pass both phases of the validation protocol, indicating it provides accurate blood pressure readings.

In contrast, the Welch-Allyn Vital Sign Monitor and Dinamap Procare-120 failed to meet the accuracy standards for diastolic blood pressure measurements, suggesting they may not be reliable for clinical use in this age group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validation of three oscillometric blood pressure devices against auscultatory mercury sphygmomanometer in children. Wong, SN., Tz Sung, RY., Leung, LC.[2019]

Ambulatory blood pressure monitoring (ABPM) is well-accepted by children and adolescents, with only 10% experiencing disturbances in behavior or sleep during the monitoring period.

ABPM provides valuable diagnostic information, with a 30% rate of fault values, and allows for detailed evaluation of blood pressure patterns, enhancing circulation diagnostics in pediatrics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Experiences with ambulatory long-term blood pressure measurement in childhood and adolescence]. Reichert, H., Hoffmann, W.[2006]

The study successfully applied 24-hour ambulatory blood pressure monitoring (ABPM) in 97 healthy infants and toddlers aged 2 to 30 months, achieving satisfactory profiles in 86.6% of participants.

The average daytime blood pressure readings were 99/62 mmHg, and nighttime readings were 95/57 mmHg, indicating that ABPM is a viable method for assessing blood pressure in very young children, with a noted increase in blood pressure correlating with height.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Twenty-four-hour ambulatory blood pressure monitoring in infants and toddlers. Varda, NM., Gregoric, A.[2022]

Citations

1. ctv.veeva.com ctv.veeva.com/study/modpg3-neo-infant-iso81060

ModPG3 Neo-Infant ISO 81060 - ClinicalTrials.Veeva The tool will automatically record the pre invasive blood pressure readings, then take the NIBP measurement with the device under test, and it ...

2. withpower.com withpower.com/trial/phase-blood-pressures-7-2023-fd572

Automated Device for High Blood Pressure in Infants The new indirect automatic blood pressure monitor for infants demonstrated high accuracy in measuring systolic blood pressure, with correlation coefficients ...

3. clinconnect.io clinconnect.io/trials/NCT05976425

ModPG3 Neo-Infant ISO 81060 (NCT05976425) - ClinConnect The ModPG3 Neo-Infant ISO 81060 clinical trial is studying how well two special algorithms, SureBP and StepBP, can measure blood pressure in newborns and ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12354324/

Accuracy and Safety of a Continuous Noninvasive Blood ... We targeted sample size of 85 subjects based on ISO 81060-2 guidelines for non-invasive blood pressure monitoring device validation, providing 80% power to ...

5. aging.networkofcare.org aging.networkofcare.org/sanmateo/CommunityResources/ClinicalTrials/Detail/NCT02125331?keyword=%22Blood%22

Measurement of NonInvasive Blood Pressure in Neonates ... ~This study will assess neonate, infant, children, pediatric, adolescent, and adult patients as well as adults with chronic atrial fibrillation in a population ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9727228/

Comparison of validation protocols for blood pressure ... In this review, we compare the validation criteria for BP measuring devices among consensus documents from different scientific organizations focusing on the ...

7. hillrom.com hillrom.com/en/products/neonatal-one-piece-disposable-blood-pressure-cuffs/

Neonatal One Piece Disposable Blood Pressure Cuffs Welch Allyn Trimline Blood Pressure Cuff; Size-01 Neonate, Soft Disposable, 1-Tube (8.0 in/20.3 cm), Male Bayonet (#5082-184) Connector; Qty. 40