Measurement of High Blood Pressure Using Boppli

June 9, 2026 updated by: Cara Slagle, Indiana University

Improving the Measurement of Neonatal High Blood Pressure Using the Boppli Device

This study evaluates a new, non-invasive device (Boppli™) that continuously measures blood pressure in newborn infants. The study compares Boppli measurements to standard blood pressure cuff measurements to determine how well the device works and whether it improves identification of high blood pressure in infants in the neonatal intensive care unit (NICU). The study also includes follow-up through 1 year of age to understand longer-term outcomes.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

High blood pressure in newborn infants (neonatal hypertension) is increasingly recognized but remains difficult to diagnose. There is no single standard definition, and current blood pressure measurements rely on intermittent cuff-based methods. These cuff measurements can be affected by infant movement, agitation, and measurement technique, which may lead to inaccurate classification of blood pressure.

The Boppli™ device is a non-invasive monitoring system that uses a soft band placed on the infant to continuously measure blood pressure using pulse wave signals. Unlike standard cuffs, the device does not inflate and may reduce measurement-related variability.

This is a prospective observational study conducted in infants admitted to the NICU who are less than 5 kg and are at risk for high blood pressure or have clinical concern for elevated blood pressure. The study does not change clinical care, and Boppli measurements will not be used for medical decision-making.

The study has three parts:

Part 1: Feasibility and Comparison of Measurements Infants will wear the Boppli device for up to 72 hours while standard blood pressure cuff measurements are collected as part of routine care. Measurements from the two methods will be compared to evaluate how closely they agree. The study will also assess how easy the device is to use and how well it is tolerated by infants, families, and clinical staff.

Part 2: Effect of Cuff Measurements on Blood Pressure Infants will continue Boppli monitoring for 72 hours. Blood pressure cuff measurements will be obtained during the first 24 hours, stopped during the second 24 hours, and resumed during the third 24 hours. This design allows the study team to evaluate whether cuff measurements themselves affect blood pressure readings. The ability of the Boppli device to identify high blood pressure will be compared to cuff-based definitions.

Part 3: Follow-up After Hospital Discharge (Exploratory) Infants with concern for high blood pressure during hospitalization will be followed through 1 year of age. Blood pressure, growth, and clinical outcomes will be collected from routine clinic visits or study visits. This part of the study will evaluate whether early blood pressure findings persist and whether infants require treatment.

The main outcome of the study is whether the Boppli device can be used successfully in the NICU and how well its measurements agree with standard cuff measurements. Additional outcomes include how accurately the device identifies high blood pressure and whether cuff measurements influence blood pressure readings. Longer-term outcomes will describe blood pressure patterns and clinical care during infancy.

This study is considered minimal risk. The device is non-invasive, and participation will not affect the medical care infants receive.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Riley Hospital for Children

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Study Population

The study population includes infants admitted to the neonatal intensive care unit (NICU) who are less than 5 kg and are at risk for elevated blood pressure or have clinical concern for hypertension. This includes infants with conditions commonly associated with higher risk of hypertension, such as kidney disease, history of acute kidney injury, or prior exposure to extracorporeal support.

Participants will be identified by the clinical care team and research staff during routine NICU care. Only infants whose parent or legal guardian provides informed consent will be enrolled. Infants currently receiving extracorporeal support (e.g., ECMO or dialysis) or with conditions that prevent device placement will be excluded.

Description

Inclusion Criteria:

  • Admitted to the neonatal intensive care unit (NICU)
  • Age 0 to 9 months at time of enrollment
  • Weight less than 5 kg
  • At risk for elevated blood pressure or with clinical concern for hypertension, -including but not limited to:
  • History of acute kidney injury or kidney disease
  • History of extracorporeal membrane oxygenation (ECMO)
  • Parent or legal guardian able to provide informed consent

Exclusion Criteria:

  • Currently receiving extracorporeal membrane oxygenation (ECMO)
  • Currently receiving any form of extracorporeal dialysis (e.g., continuous renal -replacement therapy)
  • Presence of a ventricular assist device
  • Congenital anomalies or clinical conditions that prevent placement of the Boppli™ device
  • For Part 2 only: infants not expected to survive hospitalization

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NICU Infants
Infants at-risk for chronic neonatal hypertension (cnHTN) have blood pressures assessed with the Boppli device. These assessments will be compared to those of standard inflatable cuffs.
Device: Boppli

The Boppli™ device is a non-invasive, wearable blood pressure monitoring system designed for use in neonates and infants. The device consists of a soft sensor band placed on the infant that continuously measures pulse waveforms to estimate blood pressure without the use of cuff inflation.

In this study, the device will be applied for up to 72 hours to collect continuous blood pressure data. Measurements obtained from the device will be recorded for research purposes only and will not be used to guide clinical care or medical decision-making.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility and agreement of Boppli to cuff based measurements
Time Frame: 72 hours
Feasibility will be assessed by the proportion of successful blood pressure measurements obtained using the Boppli™ device during the monitoring period and user-reported ease of use. Agreement will be assessed by comparing measurements obtained from the Boppli™ device to those obtained from standard cuff-based measurements using paired measurements.
72 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic accuracy of Boppli™ device for identification of elevated blood pressure
Time Frame: 72 hours
Sensitivity, specificity, positive predictive value, and negative predictive value of Boppli™-derived blood pressure measurements for identifying elevated blood pressure (≥95th percentile for post-menstrual age) compared to standard cuff-based definitions.
72 hours
Agreement in classification of elevated blood pressure between Boppli™ and cuff measurements
Time Frame: 72 hours
Proportion of infants classified as having elevated blood pressure (≥95th percentile for post-menstrual age) by Boppli™ monitoring compared to classification by standard cuff-based measurements.
72 hours
User-reported feasibility and acceptability of the Boppli™ device
Time Frame: 72-144 hours
Assessment of caregiver and clinical staff experience using a voluntary survey evaluating ease of use, device performance, and infant tolerance
72-144 hours

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Persistence of elevated blood pressure after hospital discharge (Exploratory)
Time Frame: ~1 year post menstrual age
Proportion of infants with elevated blood pressure during hospitalization who continue to have elevated blood pressure or require antihypertensive therapy during follow-up.
~1 year post menstrual age
Clinical outcomes associated with neonatal elevated blood pressure (Exploratory)
Time Frame: ~ 1 year post menstrual age
Assessment of growth, healthcare utilization (including follow-up visits and hospitalizations), and need for antihypertensive therapy among infants with and without elevated blood pressure during hospitalization.
~ 1 year post menstrual age

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indiana University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 30, 2026

Primary Completion (Estimated)

June 1, 2031

Study Completion (Estimated)

June 1, 2031

Study Registration Dates

First Submitted

April 17, 2026

First Submitted That Met QC Criteria

April 17, 2026

First Posted (Actual)

April 23, 2026

Study Record Updates

Last Update Posted (Actual)

June 11, 2026

Last Update Submitted That Met QC Criteria

June 9, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 30212

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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