Measurement of High Blood Pressure Using Boppli

NCT07547917 | Enrolling By Invitation FDA Device

• 1 other identifier: 30212
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypertension, Neonatal

Outcome Measures

Primary Outcomes (1)

• Feasibility and agreement of Boppli to cuff based measurements

  Feasibility will be assessed by the proportion of successful blood pressure measurements obtained using the Boppli™ device during the monitoring period and user-reported ease of use. Agreement will be assessed by comparing measurements obtained from the Boppli™ device to those obtained from standard cuff-based measurements using paired measurements.

  72 hours

Secondary Outcomes (3)

• Diagnostic accuracy of Boppli™ device for identification of elevated blood pressure

  72 hours

• Agreement in classification of elevated blood pressure between Boppli™ and cuff measurements

  72 hours

• User-reported feasibility and acceptability of the Boppli™ device

  72-144 hours

Other Outcomes (2)

• Persistence of elevated blood pressure after hospital discharge (Exploratory)

  ~1 year post menstrual age

• Clinical outcomes associated with neonatal elevated blood pressure (Exploratory)

  ~ 1 year post menstrual age

Study Arms (1)

NICU Infants

EXPERIMENTAL

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.

Device: Boppli

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.

NICU Infants

Eligibility Criteria

• Age: 0 Months - 9 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Riley Hospital for Children

Indianapolis, Indiana, 46202, United States

Location

Related Publications (14)

• Adelman RD. Long-term follow-up of neonatal renovascular hypertension. Pediatr Nephrol. 1987 Jan;1(1):35-41. doi: 10.1007/BF00866882.

  PMID: 3153258 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Jenkins RD, Aziz JK, Gievers LL, Mooers HM, Fino N, Rozansky DJ. Characteristics of hypertension in premature infants with and without chronic lung disease: a long-term multi-center study. Pediatr Nephrol. 2017 Nov;32(11):2115-2124. doi: 10.1007/s00467-017-3722-4. Epub 2017 Jul 3.

  PMID: 28674750 BACKGROUND

• Kraut EJ, Boohaker LJ, Askenazi DJ, Fletcher J, Kent AL; Neonatal Kidney Collaborative (NKC). Incidence of neonatal hypertension from a large multicenter study [Assessment of Worldwide Acute Kidney Injury Epidemiology in Neonates-AWAKEN]. Pediatr Res. 2018 Aug;84(2):279-289. doi: 10.1038/s41390-018-0018-8. Epub 2018 May 23.

  PMID: 29795211 BACKGROUND

• Sahu R, Pannu H, Yu R, Shete S, Bricker JT, Gupta-Malhotra M. Systemic hypertension requiring treatment in the neonatal intensive care unit. J Pediatr. 2013 Jul;163(1):84-8. doi: 10.1016/j.jpeds.2012.12.074. Epub 2013 Feb 7.

  PMID: 23394775 BACKGROUND

• Starr MC, Flynn JT. Neonatal hypertension: cases, causes, and clinical approach. Pediatr Nephrol. 2019 May;34(5):787-799. doi: 10.1007/s00467-018-3977-4. Epub 2018 May 28.

  PMID: 29808264 BACKGROUND

• Starr MC, Harer MW, Steflik HJ, Gorga S, Ambalavanan N, Beck TM, Chaudhry PM, Chmielewski JL, Defreitas MJ, Fuhrman DY, Hanna M, Joseph C, Kwiatkowski DM, Krawczeski CD, Liberio BM, Menon S, Mohamed TH, Rumpel JA, Sanderson KR, Schuh MP, Segar JL, Slagle CL, Soranno DE, Vuong KT, Charlton JR, Gist KM, Askenazi DJ, Selewski DT; Neonatal Kidney Health Consensus Workshop. Kidney Health Monitoring in Neonatal Intensive Care Unit Graduates: A Modified Delphi Consensus Statement. JAMA Netw Open. 2024 Sep 3;7(9):e2435043. doi: 10.1001/jamanetworkopen.2024.35043.

  PMID: 39269711 BACKGROUND

• Xiao N, Starr M, Stolfi A, Hamdani G, Hashmat S, Kiessling SG, Sethna C, Kallash M, Matloff R, Woroniecki R, Sanderson K, Yamaguchi I, Cha SD, Semanik MG, Chanchlani R, Flynn JT, Mitsnefes M. Blood Pressure Outcomes in NICU-Admitted Infants with Neonatal Hypertension: A Pediatric Nephrology Research Consortium Study. J Pediatr. 2024 Jan;264:113765. doi: 10.1016/j.jpeds.2023.113765. Epub 2023 Sep 29.

  PMID: 37778410 BACKGROUND

Related Links

• Boppli Device Website

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Care teams and providers will be aware of the infant's participation, as the Boppli device will be visible. However, as the Boppli measurements will not be used to impact clinical care, the device screen will be covered to minimize distraction. Nursing staff will periodically confirm proper connection and functioning of the device, without removing the screen cover except as necessary. The devices waveform is visible to ensure measurements are taken.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: This is an observational study of a device for blood pressure measurement in babies with high blood pressure.

Study Record Dates

• First Submitted: April 17, 2026
• First Posted: April 23, 2026
• Study Start: April 30, 2026
• Primary Completion (Estimated): June 1, 2031
• Study Completion (Estimated): June 1, 2031
• Last Updated: June 11, 2026

Record last verified: 2026-06

Locations

US (1)