Protecting Brains and Saving Futures - the PBSF Protocol

NCT03786497 | Unknown

• 1 other identifier: PBSF_2020
• Study Type: observational
• Target: 2,268
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Brain Injuries; Congenital Heart Disease; Newborn Morbidity; Intraventricular Hemorrhage; CNS Infection; Neonatal Seizure; Nosocomial Infection; Hypoxic-Ischemic Encephalopathy; Extreme Prematurity; Brain Malformation; Congenital Infection; Neonatal Stroke; Hemodynamic Instability; Extracorporeal Membrane Oxygenation Complication; Inborn Errors of Metabolism; Respiratory Complication; Neonatal Death

Keywords

Newborn; Neonatal Neurocritical Care Units; Neonatal Brain Monitoring; Brain Injury; Neuroprotection; Telemedicine; Electroencephalography; Amplitude-Integrated Electroencephalography; Near Infrared Spectroscopy; Neurodevelopmental Problems

Outcome Measures

Primary Outcomes (17)

• Applicability of telemedicine model for monitored infants

  Each outcome for all sites together will be also compared for changes over time from Year 1 (2021) to Year 3 (2023).

  3 years period

• Applicability of telemedicine model for recorded remote monitoring

  Each outcome for all sites together will be also compared for changes over time from Year 1 (2021) to Year 3 (2023).

  3 years period

• Use of aEEG/EEG monitoring

  Each outcome for all sites together will be also compared for changes over time from Year 1 (2021) to Year 3 (2023).

  3 years period

• Duration of aEEG/EEG monitoring

  Each outcome for all sites together will be also compared for changes over time from Year 1 (2021) to Year 3 (2023).

  3 years period

• Number primary neurologic or medical patients with aEEG or EEG monitoring and the duration of the monitoring (hours)

  Each outcome for all sites together will be also compared for changes over time from Year 1 (2021) to Year 3 (2023).

  3 years period

• Number of primary neurologic or medical patients with NIRS monitoring and the duration of the NIRS monitoring (hours)

  Each outcome for all sites together will be also compared for changes over time from Year 1 (2021) to Year 3 (2023).

  3 years period

• Number of primary neurologic or medical patients with brain MRI, neurology consult, and neurosurgery consult.

  Each outcome for all sites together will be also compared for changes over time from Year 1 (2021) to Year 3 (2023).

  3 years period

• Number of clinical case discussions and videoconference meetings

  Each outcome for all sites together will be also compared for changes over time from Year 1 (2021) to Year 3 (2023).

  3 years period

• Length of hospital stay

  Each outcome for all sites together will be also compared for changes over time from Year 1 (2021) to Year 3 (2023).

  3 years period

• Number of electroencephalographic seizures during hospitalization

  Each outcome for all sites together will be also compared for changes over time from Year 1 (2021) to Year 3 (2023).

  3 years period

• Use and types of anticonvulsants administered

  Each outcome for all sites together will be also compared for changes over time from Year 1 (2021) to Year 3 (2023).

  3 years period

• Number and types of anticonvulsants prescribed at discharge

  Each outcome for all sites together will be also compared for changes over time from Year 1 (2021) to Year 3 (2023).

  3 years period

• Use and types of inotropes administered during NICU stay

  Each outcome for all sites together will be also compared for changes over time from Year 1 (2021) to Year 3 (2023).

  3 years period

• Use and types of fluid resuscitation administered during NICU stay

  Each outcome for all sites together will be also compared for changes over time from Year 1 (2021) to Year 3 (2023).

  3 years period

• Death before hospital discharge

  Each outcome for all sites together will be also compared for changes over time from Year 1 (2021) to Year 3 (2023).

  3 years period

• Number of patients referred to neurology or neurosurgery

  Each outcome for all sites together will be also compared for changes over time from Year 1 (2021) to Year 3 (2023).

  3 years period

• Number of patients referred to high-risk infant follow-up

  Each outcome for all sites together will be also compared for changes over time from Year 1 (2021) to Year 3 (2023).

  3 years period

Secondary Outcomes (8)

• 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

Eligibility Criteria

• Age: Up to 3 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

This will be a multicenter, prospective, observational study in a cohort of high-risk neonates treated at 20 different Neonatal Intensive Care Units in terciary hospitals in Brazil.

You may qualify if:

• 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. Following are the indications for use of the PBSF protocol in the participating centers
• Extreme prematurity
• Peri-intraventricular Hemorrhage
• Hypoxic-ischemic encephalopathy (mild, moderate or severe)
• Congenital heart disease
• Neonatal stroke
• Congenital infections
• Nosocomial infections
• Inborn errors of metabolism
• Severe hemodynamic/ventilatory instability
• Seizures
• Brain malformations
• CNS infection
• ECMO

You may not qualify if:

• Patients with genetic syndromes or malformation incompatible with life, or older than three months old will be excluded.

Sponsors & Collaborators

• Protecting Brains Saving Futures: lead

Study Sites (2)

Irmandade da Santa Casa de Misericórdia de São Paulo

São Paulo, São Paulo, 01221-010, Brazil

Location

Protecting Brains and Saving Futures - PBSF

São Paulo, 01407-000, Brazil

Location

Related Publications (83)

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Related Links

• 25\. World Health Organization. A health telematics policy in support of WHO's Health-for-All Strategy for Global Health Development. Geneva (Switzerland); 1998.
• 26\. World Health Organization. Telemedicine: Opportunities and Development in Member States: Report on the second global survey on eHealth. Geneva (Switzerland); 2010.
• 30\. Ministério da Saúde. DATASUS. \[online\] Tabnet. \[accessed on Jan 10th 2018\]

MeSH Terms

Conditions

Brain Injuries; Heart Defects, Congenital; Central Nervous System Infections; Cross Infection; Hypoxia-Ischemia, Brain; Metabolism, Inborn Errors; Perinatal Death

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infections; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Brain Ischemia; Cerebrovascular Disorders; Hypoxia, Brain; Vascular Diseases; Hypoxia; Signs and Symptoms, Respiratory; Signs and Symptoms; Genetic Diseases, Inborn; Metabolic Diseases; Nutritional and Metabolic Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Death

Study Officials

• Guilherme M Sant'Anna, PhD

  McGill University Health Centre/Research Institute of the McGill University Health Centre

  STUDY DIRECTOR

Central Study Contacts

Gabriel FT Variane, MD

CONTACT

5511996243520; gabriel.variane@pbsf.com.br

Daniela P Rodrigues, BSN, RN, CNS

CONTACT

5511983707307; daniela.rodrigues@pbsf.com.br

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: December 12, 2018
• First Posted: December 26, 2018
• Study Start: January 1, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: November 16, 2020

Record last verified: 2020-11

Locations

BR (2)