Indiana University
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.
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 de…
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 -replacemen…
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.
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