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Protecting Brains and Saving Futures (PBSF)

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ClinicalTrials.gov Identifier: NCT03786497
Recruitment Status : Not yet recruiting
First Posted : December 25, 2018
Last Update Posted : December 25, 2018
Sponsor:
Information provided by (Responsible Party):
Dr Gabriel Variane, Protecting Brains Saving Futures

Brief Summary:

Multiple disorders in the neonatal period are associated with high risk of neurological impairment. Therapeutic hypothermia is known to be the standard treatment for infants with hypoxic ischemic encephalopathy and continuous brain monitoring, including amplitude integrated EEG and Near Infrared Spectroscopy, provides useful information for the clinician at the bedside. Despite the described benefits, it is estimated that less than 5% of Brazilian neonatal centers are well structured and trained to provide therapeutic hypothermia or continuous brain monitoring to infants at high risk. In order to reduce the existing gap, an advanced telemedicine model is proposed as an alternative to provide neuroprotection strategies in developing countries.

Methods: This is a multi-center prospective observational cohort study conducted in 20 neonatal intensive care units in Brazil. The inclusion period will be for 5 years. All patients will be assessed after hospital discharge between 18 and 24 months of life. Were included all infants admitted on the neonatal intensive care units who underwent brain monitoring with two channel aEEG/EEG and/or NIRS, presenting inclusion criteria as following: hypoxic-ischemic encephalopathy, extreme prematurity, severe peri-intraventricular hemorrhage, congenital heart disease, brain malformations, congenital infections, sepsis, inborn errors of metabolism, cardiac arrest and also seizures due to various causes. Recruitment was ahead of target by eleven months and approvals were obtained allowing recruitment to continue to the end of the planned recruitment phase.

Discussion: The Protecting Brains and Saving Futures study will evaluate the feasibility of establishing a telemedicine model to provide remote assistance to neonates at high risk for brain injury, evaluation of protocol adherence and patients who underwent TH. Furthermore, imaging findings, morbi-mortality and neurodevelopment data will be correlated.


Condition or disease Intervention/treatment
Brain Injuries Congenital Heart Disease Newborn Intraventricular Hemorrhage Meningitis Seizures Sepsis Hypoxic-Ischemic Encephalopathy Prematurity Errors Metabolism, Inborn Brain Malformation Other: Brain monitoring using PBSF protocol

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 4800 participants
Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration: 24 Months
Official Title: Protecting Brains and Saving Futures: an Observational Study on Telemedicine Neuroprotection Protocol in Neonatal Intensive Care Unit in Brazil
Estimated Study Start Date : March 2019
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2022

Intervention Details:
  • Other: Brain monitoring using PBSF protocol
    Brain function and perfusion will be monitored with two channel aEEG and NIRS by PBSF protocol via telemedicine


Primary Outcome Measures :
  1. Applicability of telemedicine model for monitored infants [ Time Frame: up to 96 hours of brain monitoring with aEEG and/or NIRS ]
    Measured by number of monitored infants per month

  2. Applicability of telemedicine model for recorded remote monitoring [ Time Frame: up to 96 hours of brain monitoring with aEEG and/or NIRS ]
    Measured by number of recorded hours of remote monitoring per month

  3. Applicability of telemedicine model for reports issued aEEG/EEG exams [ Time Frame: up to 96 hours of brain monitoring with aEEG and/or NIRS ]
    Measured by number of reports issued aEEG/EEG exams with or without the use of NIRS per month

  4. Applicability of telemedicine model for seizures identified [ Time Frame: up to 96 hours of brain monitoring with aEEG and/or NIRS ]
    Measured by number of seizures (clinical or subclinical) remotely identified per month

  5. Applicability of telemedicine model for performed TH [ Time Frame: up to 96 hours of brain monitoring with aEEG and/or NIRS ]
    Measured by number of patient who performed TH per month

  6. Applicability of telemedicine model for recorded comunications [ Time Frame: up to 96 hours of brain monitoring with aEEG and/or NIRS ]
    Measured by number of recorded remote communications between CSI and local team per month

  7. Applicability of telemedicine model for intervention as administration of medicines [ Time Frame: up to 96 hours of brain monitoring with aEEG and/or NIRS ]
    Measured by number of administration of anticonvulsivants because of communication per month

  8. Applicability of telemedicine model for intervention as change in therapeutic [ Time Frame: up to 96 hours of brain monitoring with aEEG and/or NIRS ]
    Measured by number of changes in ventilatory and hemodynamics parameters and blood transfusion because of communication per month

  9. Applicability of telemedicine model for clinical case discussion [ Time Frame: up to 96 hours of brain monitoring with aEEG and/or NIRS ]
    Measured by number of clinical case discussion videoconference meetings between hospital and monitoring center per month


Secondary Outcome Measures :
  1. Pathological brain monitoring findings and imaging exams [ Time Frame: up to 16 weeks after brain monitoring start ]
    Association of pathological brain monitoring findings (aEEG/EEG and NIRS) and alterations in imaging exams including cranial magnetic resonance imaging (cMRI) and cranial ultrasonography (cUS) performed during hospitalization.

  2. Pathological brain monitoring findings with morbi-mortality and length of hospital stay. [ Time Frame: during the hospitalization (mean 4 weeks) ]
    Association of pathological brain monitoring findings with morbi-mortality and length of hospital stay.

  3. Adverse effects of therapeutic hypothermia [ Time Frame: during the therapeutic hypothermia and rewarming period (first 84-96 hours of life) ]
    Adverse effects of therapeutic hypothermia measured by: cardiac arrhythmia, thrombocytopenia and coagulation disorders in general, skin lesion and pulmonary hypertension

  4. Adverse effects of brain monitoring [ Time Frame: during and 48 hours after the brain monitoring finish (mean 6 days) ]
    Adverse effects of brain monitoring expressed by skin lesion due to electrode / sensor positioning.

  5. Association of pathological brain monitoring findings with neurodevelopment assessment [ Time Frame: from 18 to 24 months of life ]
    neurodevelopment assessment by application of the Bayley test between 18 and 24 months of life.



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Ages Eligible for Study:   up to 1 Year   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Tertiary care/ neonatal intensive care unit
Criteria

Inclusion Criteria: All neonates who were admitted at the Neonatal Intensive Care Unit (NICU) from centers and monitored by PBSF Telemedicine System including different groups of neonates at high risk for brain injuries, as:

  • Hypoxic Ischemic Encephalopathy (HIE),
  • Prematurity and extreme low birth weight,
  • Intraventricular Hemorrhage,
  • Sepsis,
  • Meningitis,
  • Seizures,
  • Suspected seizures,
  • Congenital heart disease,
  • Ventilatory instability associated with hypoxia,
  • Hyperbilirubinemia,
  • Central nervous system malformations,
  • Cardiac arrest,
  • Inhib Error of Metabolism.

Exclusion Criteria:

  • Infants up to 365 days of life or with genetic syndromes, or congenital malformations incompatible with life.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03786497


Locations
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Brazil
Rafaela Fabri Rodrigues Pietrobom Recruiting
São Paulo, SP, Brazil, 01221010
Contact: Rafaela Pietrobom, MD    +55 11 949724721    rafaela.fabri@pbsf.com.br   
Sponsors and Collaborators
Protecting Brains Saving Futures

Additional Information:

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Responsible Party: Dr Gabriel Variane, Physician, Protecting Brains Saving Futures
ClinicalTrials.gov Identifier: NCT03786497     History of Changes
Other Study ID Numbers: PBSF_2018
First Posted: December 25, 2018    Key Record Dates
Last Update Posted: December 25, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Brain Injuries
Seizures
Brain Diseases
Meningitis
Brain Ischemia
Hypoxia-Ischemia, Brain
Cerebral Hemorrhage
Heart Diseases
Metabolism, Inborn Errors
Hemorrhage
Cardiovascular Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Pathologic Processes
Neurologic Manifestations
Signs and Symptoms
Cerebrovascular Disorders
Vascular Diseases
Hypoxia, Brain
Intracranial Hemorrhages
Genetic Diseases, Inborn
Metabolic Diseases