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Measurement of High Blood Pressure Using Boppli

NCT07547917 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2026-04-30

No results posted yet for this study

Summary

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.

Conditions

  • Hypertension, Neonatal

Interventions

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.

Sponsors & Collaborators

  • Indiana University

    lead OTHER

Eligibility

Min Age
0 Months
Max Age
9 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-13
Primary Completion
2031-06-01
Completion
2031-06-01
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07547917 on ClinicalTrials.gov