Not Yet RecruitingNot Applicable

Measurement of High Blood Pressure Using Boppli

30 participantsStarted 2026-04-13

Plain-language 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.

Who can participate

Age range0 Months – 9 Months

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Feasibility and agreement of Boppli to cuff based measurements

Timeframe: 72 hours

Trial details

NCT IDNCT07547917

SponsorIndiana University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2031-06-01

Contact for this trial

Cara L Slagle, MD

3173415752 cslagle@iuhealth.org

View on ClinicalTrials.gov More Hypertension, Neonatal trials