Protecting Brains and Saving Futures

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Protecting Brains Saving Futures

KLINIK ÇALIŞMA: NCT03786497

BioSeek: nct03786497

Anahtar kelimeler

gerstmann-straussler-scheinker disease

Öz

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.

Tarih

Son Doğrulandı:	11/30/2018
İlk Gönderilen:	12/11/2018
Tahmini Kayıt Gönderildi:	12/19/2018
İlk Gönderilen:	12/25/2018
Son Güncelleme Gönderildi:	12/19/2018
Son Güncelleme Gönderildi:	12/25/2018
Fiili Çalışma Başlangıç Tarihi:	02/28/2019
Tahmini Birincil Tamamlanma Tarihi:	05/31/2021
Tahmini Çalışma Tamamlanma Tarihi:	05/31/2022

Durum veya hastalık

Brain Injuries

Congenital Heart Disease

Newborn

Intraventricular Hemorrhage

Meningitis

Seizures

Sepsis

Hypoxic-Ischemic Encephalopathy

Prematurity

Errors Metabolism, Inborn

Brain Malformation

Müdahale / tedavi

Other: Brain monitoring using PBSF protocol

Evre

Uygunluk kriterleri

Çalışmaya Uygun Cinsiyetler	All
Örnekleme yöntemi	Non-Probability Sample
Sağlıklı Gönüllüleri Kabul Ediyor	Evet
Kriterler	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.

Sonuç

Birincil Sonuç Ölçütleri

1. Applicability of telemedicine model for monitored infants [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 [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 [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 [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 [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 [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 [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 [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 [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

İkincil Sonuç Ölçütleri

1. Pathological brain monitoring findings and imaging exams [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. [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 [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 [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 [from 18 to 24 months of life]

neurodevelopment assessment by application of the Bayley test between 18 and 24 months of life.

Protecting Brains and Saving Futures

Anahtar kelimeler

gerstmann-straussler-scheinker disease

sepsis

kanama

hipotermi

beyin iskemisi

seizures

kardiyak arrest

antifungaller