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Enrolling By Invitation
NCT07547917
Measurement of High Blood Pressure Using Boppli
Conditions: Hypertension, Neonatal
Sex: All
Ages: 0 Months – 9 Months
Healthy volunteers: No
Phase: NA
Enrollment: 30
Sponsor: Indiana University
Location: Riley Hospital for Children Indianapolis Indiana
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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT07547917). StuddyBuddy aggregates publicly available trial information.