Noninvasive Continuous BP Monitoring in Newborns Based on Pulsatile Signal Morphological Features Using NIRS

Обзор

The goal of this study is to evaluate if a novel near-infrared spectroscopy (NIRS) device can accurately estimate blood pressure in newborns at risk for unstable blood pressure. The main questions it aims to answer are: * Can NIRS accurately estimate blood pressure when compared to the gold standard, arterial line blood pressure * Can NIRS accurately estimate blood pressure when compared to infants with cuff blood pressure monitoring Researchers will compare NIRS-based estimates to arterial line blood pressure readings and manual cuff measurements to optimize and validate the FlexNIRS device for neonates to accurately estimate blood pressure continuously and noninvasively. Participants will wear a small, noninvasive NIRS sensor on the forehead.

Подробное описание

Continuous blood pressure monitoring is important for critically ill newborns to prevent brain injury caused by dysregulated changes in cerebral perfusion. In addition, continuous blood pressure monitoring is beneficial to management of many other conditions in neonates: including hypoxic-ischemic encephalopathy; for monitoring respiratory issues such as respiratory distress syndrome and pulmonary hypertension related to meconium aspiration syndrome; for managing the vascular resistance in conditions like patent ductus arteriosus and congenital heart failures; for ensuring adequate tissue perfusion during critical illness like sepsis and necrotizing enterocolitis (NEC); and for maintaining vascular tone when using inotropes or vasopressors.

The gold standard for continuous BP monitoring in newborns is via arterial line (A-line BP). However, it involves catheterization of the umbilical or a peripheral artery and can lead to complications such as vasospasm, nerve damage, ischemia, thrombosis, and, in severe cases, limb amputation. Due to these risks, A-line BP monitoring is only used when deemed necessary in critically ill neonates.

Existing noninvasive alternatives, including volume-clamp photoplethysmography cuffs, pulse-transit-time, and tonography, are problematic due to large error and safety concerns. They have been validated primarily for adults and are not tailored for neonates who pose unique challenges due to their fragile limbs, underdeveloped vasculature, immature cardiac function, and mean arterial BP often being less than a third of an adult's (30 mmHg).

To address this critical need for accurate, continuous, and noninvasive BP monitoring in newborns, the study team proposes employing a near-infrared spectroscopy (NIRS) technique on the head, focusing on pulsation tones and shapes in cerebral hemodynamics, which are sensitive to BP changes. The team has developed a wearable, battery-operated NIRS device, called FlexNIRS, capable of providing continuous photoplethysmogram (PPG) with a high temporal resolution of 266 Hz. In adults, the team has shown that the time derivative of its optical pulse waveforms d/dt(PPG) is related to pulsatile blood flow, and found strong correlations between specific features of d/dt(NIRS-PPG) and blood pressure changes. Based on these findings, it is hypothesized that NIRS-PPG collected in the brain is most ideal for neonates, especially given their fragile peripheries, and the head site allowing more robust measure of deep brain with less external factors, such as pressure from the sensor itself, room temperature, and extra arterial resistance that builds up in local peripheries. Importantly, the study team has tested the FlexNIRS in a preterm newborn and found pulsatile morphology patterns comparable to those in adults.

The current study aims to validate this novel technique for BP assessment in the newborn population from up to 80 newborns, divided evenly across Massachusetts General Hospital (MGH) and Brigham and Women's Hospital (BWH). Each measurement will involve monitoring infants with one or two FlexNIRS devices for 3-24 hours a day, for at least one day. This data will be used to refine the study team's FlexNIRS-based blood pressure estimation algorithms and correlate results with invasive A-line BP as the gold standard or periodic BP cuff readings performed by clinical staff. This research will provide invaluable data demonstrating method feasibility and initial clinical utility. The successful execution of this aim will guide the study team to a larger clinical study.

Первичные конечные точки

• FlexNIRS-based blood pressure estimation [Срок оценки: 04/09/2025 - 11/30/2026]

Критерии участия

Критерии включения

• Neonates ≥24 \& <44 weeks postmenstrual age
• Hospitalization in MGH or BWH newborn service units
• For A-line BP monitoring: Neonates expected to maintain A-line monitoring for at least the next 12 hours
• For non-A-line monitoring: Neonates at risk for unstable blood pressure (e.g. clinical instability or need for inotropes) and no contraindications to manual cuff BP measurements every 1 to 4 hours

Критерии исключения

• Contraindication to FlexNIRS device placement on the scalp/head
• Underlying congenital/genetic anomalies

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 2 центра

• Massachusettes General Hospital — Boston
• Brigham and Women's Hospital — Boston

Публикации

• Wu KC, Martin A, Renna M, Robinson M, Ozana N, Carp SA, Franceschini MA. Enhancing diffuse correlation spectroscopy pulsatile cerebral blood flow signal with near-infrared spectroscopy photoplethysmography. Neurophotonics. 2023 Jul;10(3):035008. doi: 10.1117/1.NPh.10.3.035008. Epub 2023 Sep 6. PMID 37680339
• Wu KC, Tamborini D, Renna M, Peruch A, Huang Y, Martin A, Kaya K, Starkweather Z, Zavriyev AI, Carp SA, Salat DH, Franceschini MA. Open-source FlexNIRS: A low-cost, wireless and wearable cerebral health tracker. Neuroimage. 2022 Aug 1;256:119216. doi: 10.1016/j.neuroimage.2022.119216. Epub 2022 Apr 19. PMID 35452803
• Boas DA, Strangman G, Culver JP, Hoge RD, Jasdzewski G, Poldrack RA, Rosen BR, Mandeville JB. Can the cerebral metabolic rate of oxygen be estimated with near-infrared spectroscopy? Phys Med Biol. 2003 Aug 7;48(15):2405-18. doi: 10.1088/0031-9155/48/15/311. PMID 12953906
• Murkin JM, Arango M. Near-infrared spectroscopy as an index of brain and tissue oxygenation. Br J Anaesth. 2009 Dec;103 Suppl 1:i3-13. doi: 10.1093/bja/aep299. PMID 20007987
• Gonzalez S, Hsieh WT, Chen TP. A benchmark for machine-learning based non-invasive blood pressure estimation using photoplethysmogram. Sci Data. 2023 Mar 21;10(1):149. doi: 10.1038/s41597-023-02020-6. PMID 36944668
• Troy R, Doron M, Laughon M, Tolleson-Rinehart S, Price W. Comparison of noninvasive and central arterial blood pressure measurements in ELBW infants. J Perinatol. 2009 Nov;29(11):744-9. doi: 10.1038/jp.2009.86. Epub 2009 Jul 16. PMID 19609309
• Dionne JM. Determinants of Blood Pressure in Neonates and Infants: Predictable Variability. Hypertension. 2021 Mar 3;77(3):781-787. doi: 10.1161/HYPERTENSIONAHA.120.14587. Epub 2021 Feb 10. PMID 33566691
• Rao A, Eskandar-Afshari F, Weiner Y, Billman E, McMillin A, Sella N, Roxlo T, Liu J, Leong W, Helfenbein E, Walendowski A, Muir A, Joseph A, Verma A, Ramamoorthy C, Honkanen A, Green G, Drake K, Govindan RB, Rhine W, Quan X. Clinical Study of Continuous Non-Invasive Blood Pressure Monitoring in Neonates. Sensors (Basel). 2023 Apr 2;23(7):3690. doi: 10.3390/s23073690. PMID 37050750

Идентификаторы

NCT: NCT06994494 · 2024P000562 · 1R21HD117308-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗