Protecting Brains and Saving Futures - the PBSF Protocol: a Prospective Multicenter and Observational Study on the Use of Telemedicine for Neurocritical Care in High-risk Newborns in Brazil.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 2,268
- 试验地点
- 2
- 主要终点
- Applicability of telemedicine model for monitored infants
研究概览
简要总结
Background: Multiple neonatal disorders are associated with risks of neurological injury. Thus, management of these infants should involve a coordinated approach to permit early diagnosis with improved clinical care. Such initiative involves the use of standardized protocols, continuous and specialized brain monitoring with electroencephalography (EEG), amplitude integrated EEG (aEEG) and Near Infrared Spectroscopy (NIRS), neuroimaging and training. Brazil is a very large country with disparities in health care assessment; some neonatal intensive care units (NICUs) are not well structured and trained to provide adequate neurocritical care. However, the development and implementation of these neurocritical care units requires high expertise and significant investment of time, manpower and equipment. In order to reduce the existing gap, a unique advanced telemedicine model of neurocritical care called Protecting Brains and Saving Futures (PBSF) protocol was developed and implemented in some Brazilian NICUs.
Methods: A prospective observational cohort study will be conducted in 20 Brazilian NICUs that have adopted the PBSF protocol. All infants receiving the protocol during January 2021 to December 2023 will be eligible. Ethical approval will be obtained from the participating institutions. The primary objective is to describe the use of the PBSF protocol and clinical outcomes, by center and over a 3 years period. The use of the PBSF protocol will be measured by quantification of neuromonitoring, neuroimaging exams and sub-specialties consultation. Clinical outcomes of interest after the protocol implementation are length of hospital stay, detection of EEG seizures during hospitalization, use of anticonvulsants, inotropes, and fluid resuscitation, death before hospital discharge, and referral of patients to high-risk infant follow-up. These data will be also compared between infants with primarily neurologic and primarily clinical diagnosis.
Discussion: The implementation of the PBSF protocol may provide adequate remote neurocritical care in high-risk infants with optimization of clinical management and improved outcomes. Data from this large, prospective, multicenter study are essential to determine whether neonatal neurocritical units can improve outcomes. Finally, it may offer the necessary framework for larger scale implementation and help in the development of studies of remote neuromonitoring.
详细描述
METHODS Objectives The aim of this multicenter, prospective, cohort study is to describe the use of the PBSF protocol and clinical outcomes, by center and over a 3 years period (2021 to 2023) in the NICUs that have adopted it. We hypothesize that the use of the PBSF protocol will increase over time with improvement of some specific short-term outcomes (see methods below). Results of this study may provide the necessary background information for larger studies and initiatives aiming to protect neonatal brains and save futures.
Study Design and Setting This will be a multicenter, prospective, observational study in a cohort of high-risk neonates treated at 20 different NICU's in Brazil. The intended period of patient recruitment and data collection will be 3 years (January 2021 to December 2023). The study followed the precepts of good clinical practice and was approved by the Research Ethics Committee of the Irmandade da Santa Casa de Misericórdia de São Paulo. In addition, the project has received formal authorization from the Clinical and Administrative Board of each center. When selecting a participant, the principal investigator of the study or one of the co-investigators will contact the parents or guardians and obtain informed consent. All data will be treated anonymously and confidentially, and in no phase of the study any name, image, or data that allows participants identification will be disclosed.
Participants In this cohort study, all the infants admitted to any of the 20 NICUs from birth up to three months of life and receiving the PBSF protocol are eligible. Indications for the use of the protocol are provided on Box 1. Patients with genetic syndromes or malformation incompatible with life, or older than three months old will be excluded. Details on the PBSF protocol are provided in supplemental material. Briefly, the protocol includes provision of equipment and resources, connection between the associated NICU and the remote monitoring center called the Central of Surveillance and Intelligence (CSI), training and teaching of all health care professional team of each NICU, and customized multiparametric recordings of biological signals of each patient monitoring. At the CSI, a team is available 24 hours a day all year around, allowing for case discussions and simplified reports of brain monitoring information on the patient monitor's display every 6 hours.
Variables Population demographics: gender, gestational age at birth, gestational age ≤ 32 weeks and < 37 weeks, Apgar score at 1 min, 5 min and 10 min, birth weight, current weight, inborn or outborn, use of antenatal steroids and magnesium sulfate, type of birth.
Primary diagnosis: seizure, anoxia/mild HIE, moderate or severe HIE/cooling, neurologic abnormalities without specific diagnosis, congenital central nervous system (CNS) anomalies, grade III or IV intraventricular hemorrhage (IVH) or hydrocephalus, periventricular leukomalacia, meningitis, neural tube defects, stroke, cyanotic congenital heart defect (CHD), prematurity, gestational age ≤ 32 weeks, meconium aspiration syndrome, cardiorespiratory instability, necrotizing enterocolitis, metabolic disease, extracorporeal membrane oxygenation (ECMO)/pre-ECMO and any other medical conditions not listed here.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 3 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Applicability of telemedicine model for monitored infants
时间窗: 3 years period
Each outcome for all sites together will be also compared for changes over time from Year 1 (2021) to Year 3 (2023).
Applicability of telemedicine model for recorded remote monitoring
时间窗: 3 years period
Each outcome for all sites together will be also compared for changes over time from Year 1 (2021) to Year 3 (2023).
Use of aEEG/EEG monitoring
时间窗: 3 years period
Each outcome for all sites together will be also compared for changes over time from Year 1 (2021) to Year 3 (2023).
Duration of aEEG/EEG monitoring
时间窗: 3 years period
Each outcome for all sites together will be also compared for changes over time from Year 1 (2021) to Year 3 (2023).
Number primary neurologic or medical patients with aEEG or EEG monitoring and the duration of the monitoring (hours)
时间窗: 3 years period
Each outcome for all sites together will be also compared for changes over time from Year 1 (2021) to Year 3 (2023).
Number of primary neurologic or medical patients with NIRS monitoring and the duration of the NIRS monitoring (hours)
时间窗: 3 years period
Each outcome for all sites together will be also compared for changes over time from Year 1 (2021) to Year 3 (2023).
Number of primary neurologic or medical patients with brain MRI, neurology consult, and neurosurgery consult.
时间窗: 3 years period
Each outcome for all sites together will be also compared for changes over time from Year 1 (2021) to Year 3 (2023).
Number of clinical case discussions and videoconference meetings
时间窗: 3 years period
Each outcome for all sites together will be also compared for changes over time from Year 1 (2021) to Year 3 (2023).
Length of hospital stay
时间窗: 3 years period
Each outcome for all sites together will be also compared for changes over time from Year 1 (2021) to Year 3 (2023).
Number of electroencephalographic seizures during hospitalization
时间窗: 3 years period
Each outcome for all sites together will be also compared for changes over time from Year 1 (2021) to Year 3 (2023).
Use and types of anticonvulsants administered
时间窗: 3 years period
Each outcome for all sites together will be also compared for changes over time from Year 1 (2021) to Year 3 (2023).
Number and types of anticonvulsants prescribed at discharge
时间窗: 3 years period
Each outcome for all sites together will be also compared for changes over time from Year 1 (2021) to Year 3 (2023).
Use and types of inotropes administered during NICU stay
时间窗: 3 years period
Each outcome for all sites together will be also compared for changes over time from Year 1 (2021) to Year 3 (2023).
Use and types of fluid resuscitation administered during NICU stay
时间窗: 3 years period
Each outcome for all sites together will be also compared for changes over time from Year 1 (2021) to Year 3 (2023).
Death before hospital discharge
时间窗: 3 years period
Each outcome for all sites together will be also compared for changes over time from Year 1 (2021) to Year 3 (2023).
Number of patients referred to neurology or neurosurgery
时间窗: 3 years period
Each outcome for all sites together will be also compared for changes over time from Year 1 (2021) to Year 3 (2023).
Number of patients referred to high-risk infant follow-up
时间窗: 3 years period
Each outcome for all sites together will be also compared for changes over time from Year 1 (2021) to Year 3 (2023).
次要结局
- Number of remote communications between CSI and local team(3 years period)
- Number of reports issued for aEEG / EEG exams with or without the use of NIRS(3 years period)
- Number of patients who performed Therapeutic Hypothermia(3 years period)
- Association of pathological brain monitoring findings (aEEG/EEG and NIRS) and alterations in imaging exams including brain magnetic resonance imaging (brain MRI) and cranial ultrasonography (cranial US) performed during hospitalization(3 years period)
- Association of pathological brain monitoring findings with morbi-mortality and length of hospital stay(3 years period)
- Adverse effects of therapeutic hypothermia measured by cardiac arrhythmia, thrombocytopenia and coagulation disorders in general, skin lesion and pulmonary hypertension(3 years period)
- Adverse effects of brain monitoring expressed by skin lesion due to electrode / sensor positioning(3 years period)
- Association of pathological brain monitoring findings with evaluation of neurodevelopment by application of the Bayley test between 18 and 24 months of life(3 years period)
研究者
Dr Gabriel Variane
Physician
Protecting Brains Saving Futures