Measurement of High Blood Pressure Using Boppli

Official title

Improving the Measurement of Neonatal High Blood Pressure Using the Boppli Device

Overview

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.

Detailed description

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 device does not inflate and may reduce measurement-related variability.

This is a prospective observational study conducted in infants admitted to the NICU who are less than 5 kg and are at risk for high blood pressure or have clinical concern for elevated blood pressure. The study does not change clinical care, and Boppli measurements will not be used for medical decision-making.

The study has three parts:

Part 1: Feasibility and Comparison of Measurements Infants will wear the Boppli device for up to 72 hours while standard blood pressure cuff measurements are collected as part of routine care. Measurements from the two methods will be compared to evaluate how closely they agree. The study will also assess how easy the device is to use and how well it is tolerated by infants, families, and clinical staff.

Part 2: Effect of Cuff Measurements on Blood Pressure Infants will continue Boppli monitoring for 72 hours. Blood pressure cuff measurements will be obtained during the first 24 hours, stopped during the second 24 hours, and resumed during the third 24 hours. This design allows the study team to evaluate whether cuff measurements themselves affect blood pressure readings. The ability of the Boppli device to identify high blood pressure will be compared to cuff-based definitions.

Part 3: Follow-up After Hospital Discharge (Exploratory) Infants with concern for high blood pressure during hospitalization will be followed through 1 year of age. Blood pressure, growth, and clinical outcomes will be collected from routine clinic visits or study visits. This part of the study will evaluate whether early blood pressure findings persist and whether infants require treatment.

The main outcome of the study is whether the Boppli device can be used successfully in the NICU and how well its measurements agree with standard cuff measurements. Additional outcomes include how accurately the device identifies high blood pressure and whether cuff measurements influence blood pressure readings. Longer-term outcomes will describe blood pressure patterns and clinical care during infancy.

This study is considered minimal risk. The device is non-invasive, and participation will not affect the medical care infants receive.

Interventions

• Device Boppli
  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

Primary outcome measures

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

Secondary outcome measures (3)

• Diagnostic accuracy of Boppli™ device for identification of elevated blood pressure [Time frame: 72 hours]
• Agreement in classification of elevated blood pressure between Boppli™ and cuff measurements [Time frame: 72 hours]
• User-reported feasibility and acceptability of the Boppli™ device [Time frame: 72-144 hours]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Diagnostic

Study locations

United States · 1 center

• Riley Hospital for Children — Indianapolis

Publications

• Adelman RD. Long-term follow-up of neonatal renovascular hypertension. Pediatr Nephrol. 1987 Jan;1(1):35-41. doi: 10.1007/BF00866882. PMID 3153258
• AlMaazmi A, Hagan J, Fernandes CJ, Gowda SH. Neonatal systemic hypertension across the PHIS database: An update. Int J Cardiol. 2023 Apr 1;376:49-53. doi: 10.1016/j.ijcard.2023.01.060. Epub 2023 Jan 20. PMID 36682689
• Dionne JM. Updated Guideline May Improve the Recognition and Diagnosis of Hypertension in Children and Adolescents; Review of the 2017 AAP Blood Pressure Clinical Practice Guideline. Curr Hypertens Rep. 2017 Oct 16;19(10):84. doi: 10.1007/s11906-017-0780-8. PMID 29035421
• Dionne JM, Abitbol CL, Flynn JT. Hypertension in infancy: diagnosis, management and outcome. Pediatr Nephrol. 2012 Jan;27(1):17-32. doi: 10.1007/s00467-010-1755-z. Epub 2011 Jan 22. PMID 21258818
• Flynn JT, Kaelber DC, Baker-Smith CM, et al; Subcommittee on Screening and Management of High Blood Pressure in Children. Clinical Practice Guideline for Screening and Management of High Blood Pressure in Children and Adolescents. Pediatrics. 2017;140(3):e20171904. Pediatrics. 2018 Sep;142(3):e20181739. doi: 10.1542/peds.2018-1739. No abstract available. PMID 30177515
• Flynn RS, Zedalis J, Denburg MR, Bernbaum JC, DeMauro SB. Improving Blood Pressure Screening in Neonatal Follow-up Clinic: A Quality Improvement Initiative. Pediatr Qual Saf. 2022 Jun 14;7(3):e559. doi: 10.1097/pq9.0000000000000559. eCollection 2022 May-Jun. PMID 35720869
• Friedman AL, Hustead VA. Hypertension in babies following discharge from a neonatal intensive care unit. A 3-year follow-up. Pediatr Nephrol. 1987 Jan;1(1):30-4. doi: 10.1007/BF00866881. PMID 3153257
• Harer MW, Selewski DT, Kashani K, Basu RK, Gist KM, Jetton JG, Sutherland SM, Zappitelli M, Goldstein SL, Mottes TA, Askenazi DJ. Improving the quality of neonatal acute kidney injury care: neonatal-specific response to the 22nd Acute Disease Quality Initiative (ADQI) conference. J Perinatol. 2021 Feb;41(2):185-195. doi: 10.1038/s41372-020-00810-z. Epub 2020 Sep 5. PMID 32892210

Identifiers

NCT: NCT07547917 · 30212

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗