[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07547917":3,"trial-entities:NCT07547917":133,"trial-summary:NCT07547917":137},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":35,"secondary_outcomes":40,"sex":51,"minimum_age":52,"maximum_age":53,"healthy_volunteers":54,"eligibility_criteria":55,"std_ages":71,"locations":73,"central_contacts":83,"overall_officials":84,"references":85,"see_also_links":129},"NCT07547917","30212","Measurement of High Blood Pressure Using Boppli","Improving the Measurement of Neonatal High Blood Pressure Using the Boppli Device","ENROLLING_BY_INVITATION","2031-06-01","2026-06","2026-06-11","2026-04-30","Indiana University","OTHER",null,"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.\n\nThe 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.\n\nThis 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.\n\nThe study has three parts:\n\nPart 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.\n\nPart 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.\n\nPart 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.\n\nThe 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.\n\nThis study is considered minimal risk. The device is non-invasive, and participation will not affect the medical care infants receive.",[19],"Hypertension, Neonatal",[],"INTERVENTIONAL","DIAGNOSTIC",[24],"NA",{"count":26,"type":27},30,"ESTIMATED",[29],{"type":30,"name":31,"description":32,"armGroupLabels":33},"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.\n\nIn 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.",[34],"NICU Infants",[36],{"measure":37,"description":38,"timeFrame":39},"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",[41,44,47],{"measure":42,"description":43,"timeFrame":39},"Diagnostic accuracy of Boppli™ device for identification of elevated blood pressure","Sensitivity, specificity, positive predictive value, and negative predictive value of Boppli™-derived blood pressure measurements for identifying elevated blood pressure (≥95th percentile for post-menstrual age) compared to standard cuff-based definitions.",{"measure":45,"description":46,"timeFrame":39},"Agreement in classification of elevated blood pressure between Boppli™ and cuff measurements","Proportion of infants classified as having elevated blood pressure (≥95th percentile for post-menstrual age) by Boppli™ monitoring compared to classification by standard cuff-based measurements.",{"measure":48,"description":49,"timeFrame":50},"User-reported feasibility and acceptability of the Boppli™ device","Assessment of caregiver and clinical staff experience using a voluntary survey evaluating ease of use, device performance, and infant tolerance","72-144 hours","ALL","0 Months","9 Months",false,{"inclusion":56,"exclusion":64,"raw_text":70},[57,58,59,60,61,62,63],"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",[65,66,67,68,69],"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","Inclusion Criteria:\n\n* Admitted to the neonatal intensive care unit (NICU)\n* Age 0 to 9 months at time of enrollment\n* Weight less than 5 kg\n* At risk for elevated blood pressure or with clinical concern for hypertension, -including but not limited to:\n* History of acute kidney injury or kidney disease\n* History of extracorporeal membrane oxygenation (ECMO)\n* Parent or legal guardian able to provide informed consent\n\nExclusion Criteria:\n\n* Currently receiving extracorporeal membrane oxygenation (ECMO)\n* Currently receiving any form of extracorporeal dialysis (e.g., continuous renal -replacement therapy)\n* Presence of a ventricular assist device\n* Congenital anomalies or clinical conditions that prevent placement of the Boppli™ device\n* For Part 2 only: infants not expected to survive hospitalization",[72],"CHILD",[74],{"facility":75,"city":76,"state":77,"zip":78,"country":79,"geoPoint":80},"Riley Hospital for Children","Indianapolis","Indiana","46202","United States",{"lat":81,"lon":82},39.76838,-86.15804,[],[],[86,90,93,96,99,102,105,108,111,114,117,120,123,126],{"pmid":87,"type":88,"citation":89},"3153258","BACKGROUND","Adelman RD. Long-term follow-up of neonatal renovascular hypertension. Pediatr Nephrol. 1987 Jan;1(1):35-41. doi: 10.1007\u002FBF00866882.",{"pmid":91,"type":88,"citation":92},"36682689","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\u002Fj.ijcard.2023.01.060. Epub 2023 Jan 20.",{"pmid":94,"type":88,"citation":95},"29035421","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\u002Fs11906-017-0780-8.",{"pmid":97,"type":88,"citation":98},"21258818","Dionne JM, Abitbol CL, Flynn JT. Hypertension in infancy: diagnosis, management and outcome. Pediatr Nephrol. 2012 Jan;27(1):17-32. doi: 10.1007\u002Fs00467-010-1755-z. Epub 2011 Jan 22.",{"pmid":100,"type":88,"citation":101},"30177515","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\u002Fpeds.2018-1739. No abstract available.",{"pmid":103,"type":88,"citation":104},"35720869","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\u002Fpq9.0000000000000559. eCollection 2022 May-Jun.",{"pmid":106,"type":88,"citation":107},"3153257","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\u002FBF00866881.",{"pmid":109,"type":88,"citation":110},"32892210","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\u002Fs41372-020-00810-z. Epub 2020 Sep 5.",{"pmid":112,"type":88,"citation":113},"28674750","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\u002Fs00467-017-3722-4. Epub 2017 Jul 3.",{"pmid":115,"type":88,"citation":116},"29795211","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\u002Fs41390-018-0018-8. Epub 2018 May 23.",{"pmid":118,"type":88,"citation":119},"23394775","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\u002Fj.jpeds.2012.12.074. Epub 2013 Feb 7.",{"pmid":121,"type":88,"citation":122},"29808264","Starr MC, Flynn JT. Neonatal hypertension: cases, causes, and clinical approach. Pediatr Nephrol. 2019 May;34(5):787-799. doi: 10.1007\u002Fs00467-018-3977-4. Epub 2018 May 28.",{"pmid":124,"type":88,"citation":125},"39269711","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\u002Fjamanetworkopen.2024.35043.",{"pmid":127,"type":88,"citation":128},"37778410","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\u002Fj.jpeds.2023.113765. Epub 2023 Sep 29.",[130],{"label":131,"url":132},"Boppli Device Website","https:\u002F\u002Fpyrameshealth.com\u002Four-platforms\u002Fboppli-platform\u002F",{"nct_id":4,"conditions":134,"biomarkers":136},[135],"Neonatal Hypertension",[],{"nct_id":4,"found":54,"summary":15,"prompt_version":15}]