Automated Device for High Blood Pressure in Infants

Recruiting at 1 trial location

Overseen By Baxter Clinical Trials Disclosure Call Center

Age: < 18

Sex: Any

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

18 Participants Needed

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. ^{1 2 3 4 5}

Is the automated device for high blood pressure in infants safe for use?

The automated blood pressure monitor for infants has been shown to be safe and accurate, with no significant problems reported during its use in studies with infants and newborns. ^{1 2 5 6 7}

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. ^{1 2 4 8 9}

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

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

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 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 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 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 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]

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]

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Twenty-four-hour ambulatory blood pressure monitoring in infants and toddlers. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Indirect measurement of blood pressure in neonates and infants utilizing an automatic noninvasive oscillometric monitor. [2004]

3. Brazil pubmed.ncbi.nlm.nih.gov

[Evaluation of the Omron 705-CP blood pressure measuring device for use in adolescents and young adults]. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Home blood pressure monitoring in diabetes. [2019]

5. India 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? [2019]

6. England pubmed.ncbi.nlm.nih.gov

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

7. England pubmed.ncbi.nlm.nih.gov

Validation of three oscillometric blood pressure devices against auscultatory mercury sphygmomanometer in children. [2019]

8. Germany pubmed.ncbi.nlm.nih.gov

Utility of ambulatory blood pressure monitoring in children and adolescents. [2018]

9. Germany pubmed.ncbi.nlm.nih.gov

[Experiences with ambulatory long-term blood pressure measurement in childhood and adolescence]. [2006]