Measurement of High Blood Pressure Using Boppli

Conditions

• Hypertension, Neonatal

Eligibility Criteria

Sex

ALL

Age

0 Months - 9 Months

Healthy Volunteers

Not accepted

Interventions

• Boppli — DEVICE
  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.

Study Details

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.

Key Dates

Start date

Apr 30, 2026

Status verified

Jun 2026

Primary completion

Jun 1, 2031

Completion

Jun 1, 2031

Study Design

Enrollment

30 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Arms

• 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.

Primary Outcome Measure

Feasibility and agreement of Boppli to cuff based measurements [ Time Frame: 72 hours ]

Locations (1)

Find similar trials in Indianapolis, IN