Improving Measurement of Neonatal High Blood Pressure Using the Boppli Device

Investigating Blood Pressure Measurement in Infants Using an Investigational Device

C
Cara Slagle

Primary Investigator

Enrolling By Invitation
9 months or below
All
Phase N/A
30 participants needed
1 Location

Brief description of study

The purpose of this study is to test how well a new soft, wearable blood pressure device (Boppli™) measures blood pressure in babies compared to the standard blood pressure cuff used in the NICU. We will also look at whether cuff measurements may temporarily raise a baby’s blood pressure. Information from this study may help improve how high blood pressure is monitored in infants in the future.

THIS STUDY IS ENROLLING BY INVITATION ONLY - Potential participants will be identified through review of hospitalized infants in the Simon Family Tower NICU by the neonatal nephrology and neonatology research teams based on documented eligibility criteria in the medical record. Once an eligible infant is identified, the primary clinical team will be consulted to confirm that it is appropriate to approach the family. A trained member of the study team will then contact the parent or guardian in person in the NICU or remotely via phone call to introduce the study and review participation. Clinicians will be identified through through documentation in Cerner or through the daily unit attending assignment sheet. RNs will be identified at the bedside at the time of communication about the study or through documentation in Cerner.

Detailed description of study

This is a prospective observational clinical study that will enroll a cohort of infants. There are three parts of the study for patients, with interim analysis after part 1 to verify that Boppli can accurately classify patients for Parts 2 and 3 to remain open to enrollment. 

    Part 1: We will enroll infants (N=30) with a risk of elevated blood pressures.  
    Part 2: Infants enrolled in Part 1 who are anticipated to survive until discharge (N=25)  
    Part 3: Infants enrolled in Part 1 and 2 who complete follow-up through nephrology or telephone or study visits (N=20)

The overarching objective is to demonstrate that Boppli implementation is feasible and non-inferior to cuff pressures and determine ability to more accurately identify patients with concerns of hypertension (consistently elevated BP 95%ile). Thus the overall objective is to first determine feasibility and consistent classification between the devices during simultaneous times (as performed during interim analysis to verify before continuing to enroll in part 2), and then examine the impact of cuff on blood pressure, followed by an exploratory analysis of understanding more longitudinal outcomes and potential impact.

All research procedures will occur in the Simon Family Tower Neonatal Intensive Care Unit (NICU) while infants are hospitalized.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Chronic hypertension, cnHTN, Acute kidney injury, AKI, Chronic kidney diseasel, Riley
  • Age: 9 months or below
  • Gender: All

Infant Inclusion Criteria

  • Admitted to the Simon Family Tower NICU.
  • 0-9 months of age
  • Any infant at-risk for cnHTN (infants with known AKI or kidney disease, or history of treatment with extracorporeal membrane oxygenation), or concerns for HTN)
     

Infant Exclusion Criteria

  • Currently receiving Extracorporeal Membrane Oxygenation or any form of extracorporeal dialysis (continuous renal replacement therapy) 
  • Recipient of a Left Ventricular assist device 
  • Patients with congenital anomalies that do not allow for device placement

This study investigates how well a new wearable device measures blood pressure in infants compared to the usual blood pressure cuff used in hospitals. The purpose of this study is to see if the new device can accurately measure blood pressure without causing any changes in the baby's blood pressure. High blood pressure, also known as hypertension, can be a concern in infants, especially those with certain health conditions.

In this study, infants will have their blood pressure measured with both the new device and the standard cuff. The study is divided into three parts, with each part involving different groups of infants. The goal is to see if the new device can consistently measure blood pressure accurately. All procedures will take place in the neonatal intensive care unit while the infants are in the hospital.

  • Who can participate: Infants admitted to the Simon Family Tower NICU who are 0-9 months old and at risk for high blood pressure, such as those with kidney problems or treated with certain machines, may participate. Infants currently using certain medical devices or with specific health conditions cannot participate.
  • Study details: Participants will have their blood pressure measured using both the investigational device and the standard cuff. The study will observe how these measurements compare while the infants are in the hospital. This observational study, which involves monitoring participants without altering their treatment, will not change the infants' treatment.
Updated on 12 May 2026. Study ID: PNEO-IIR-BOPPLI, 30212
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Interested in the study?

This study is accepting only persons who receive care at a certain clinic or doctor or who are part of an invited group. Questions about this study can be directed to the study team listed in the description or contact your doctor to see if you are eligible.

Accepting Referrals by Invitation Only