Status:
UNKNOWN
Protecting Brains and Saving Futures - the PBSF Protocol
Lead Sponsor:
Protecting Brains Saving Futures
Conditions:
Brain Injuries
Congenital Heart Disease
Eligibility:
All Genders
Up to 3 years
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 improve...
Detailed Description
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 N...
Eligibility Criteria
Inclusion
- \- Inclusion criteria:
- 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
- Exclusion criteria:
- Patients with genetic syndromes or malformation incompatible with life, or older than three months old will be excluded.
Exclusion
Key Trial Info
Start Date :
January 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2023
Estimated Enrollment :
2268 Patients enrolled
Trial Details
Trial ID
NCT03786497
Start Date
January 1 2021
End Date
December 31 2023
Last Update
November 16 2020
Active Locations (2)
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1
Irmandade da Santa Casa de Misericórdia de São Paulo
São Paulo, São Paulo, Brazil, 01221-010
2
Protecting Brains and Saving Futures - PBSF
São Paulo, Brazil, 01407-000