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

PLoS One. 2022 Jan 12;17(1):e0262581. doi: 10.1371/journal.pone.0262581. eCollection 2022.

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.

Publication types

  • Clinical Trial Protocol
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Brain / physiology*
  • Delivery of Health Care / standards*
  • Female
  • Humans
  • Infant
  • Infant, Newborn
  • Infant, Newborn, Diseases / prevention & control*
  • Intensive Care Units, Neonatal / standards*
  • Male
  • Multicenter Studies as Topic
  • Neuroimaging
  • Neurophysiological Monitoring
  • Observational Studies as Topic
  • Practice Guidelines as Topic / standards*
  • Prospective Studies
  • Seizures / diagnosis*
  • Seizures / diagnostic imaging
  • Telemedicine / methods*
  • Video Recording

Associated data

  • ClinicalTrials.gov/NCT03786497

Grants and funding

GFTV and AN received funds from the Protecting Brain and Saving Futures (PBSF) Organization (www.pbsf.com.br). Both authors were involved in the design of the study, data collection and analysis, writing of the final manuscript, and decision to publish. PBSF Organization is registered with CNPJ 28.905.143/0001-61, headquartered at Av. Nove de Julho, 3229 – 13rd floor, room 1301 – Jardim Paulista, São Paulo, SP, Brazil – 01407-000, E-mail: contato@pbsf.com.br; Phone: + 55 (11) 3044-2557.