Protecting brains and saving futures guidelines: A prospective, multicenter, and observational study on the use of telemedicine for neonatal neurocritical care in Brazil

Gabriel Fernando Todeschi Variane, Maurício Magalhães, Rafaela Fabri Rodrigues Pietrobom, Alexandre Netto, Daniela Pereira Rodrigues, Renato Gasperini, Guilherme Mendes Sant'Anna, Gabriel Fernando Todeschi Variane, Maurício Magalhães, Rafaela Fabri Rodrigues Pietrobom, Alexandre Netto, Daniela Pereira Rodrigues, Renato Gasperini, Guilherme Mendes Sant'Anna

Abstract

Background: Management of high-risk newborns should involve the use of standardized protocols and training, continuous and specialized brain monitoring with electroencephalography (EEG), amplitude integrated EEG, Near Infrared Spectroscopy, and neuroimaging. Brazil is a large country with disparities in health care assessment and some neonatal intensive care units (NICUs) are not well structured with trained personnel able to provide adequate neurocritical care. To reduce this existing gap, an advanced telemedicine model of neurocritical care called Protecting Brains and Saving Futures (PBSF) Guidelines was developed and implemented in a group of Brazilian NICUs.

Methods: A prospective, multicenter, and observational study will be conducted in all 20 Brazilian NICUs using the PBSF Guidelines as standard-of-care. All infants treated accordingly to the guidelines during Dec 2021 to Nov 2024 will be eligible. Ethical approval was obtained from participating centers. The primary objective is to describe adherence to the PBSF Guidelines and clinical outcomes, by center and over a 3-year period. Adherence will be measured by quantification of neuromonitoring, neuroimaging exams, sub-specialties consultation, and clinical case discussions and videoconference meetings. Clinical outcomes of interest are detection of seizures during hospitalization, use of anticonvulsants, inotropes, and fluid resuscitation, death before hospital discharge, length of hospital stay, and referral of patients to specialized follow-up.

Discussion: The study will provide evaluation of PBSF Guidelines adherence and its impact on clinical outcomes. Thus, data from this large prospective, multicenter, and observational study will help determine whether neonatal neurocritical care via telemedicine can be effective. Ultimately, it may offer the necessary framework for larger scale implementation and development of research projects using remote neuromonitoring.

Trial registration: NCT03786497, Registered 26 December 2018, https://www.clinicaltrials.gov/ct2/show/NCT03786497?term=protecting+brains+and+saving+futures&draw=2&rank=1.

Conflict of interest statement

Gabriel FT Variane and Alexandre Netto are the owners of PBSF and Guilherme M Sant’Anna has no conflicts of interest and no financial relationships relevant to this article to disclose. All other authors work at PBSF.

Figures

Fig 1. Schedule of enrollment, interventions, and…
Fig 1. Schedule of enrollment, interventions, and assessments.

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