Protecting Brains and Saving Futures

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Protecting Brains Saving Futures

临床试验: NCT03786497

BioSeek: nct03786497

关键词

gerstmann-straussler-scheinker disease

抽象

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.

日期

最后验证:	11/30/2018
首次提交:	12/11/2018
提交的预估入学人数:	12/19/2018
首次发布:	12/25/2018
上次提交的更新:	12/19/2018
最近更新发布:	12/25/2018
实际学习开始日期:	02/28/2019
预计主要完成日期:	05/31/2021
预计完成日期:	05/31/2022

状况或疾病

Brain Injuries

Congenital Heart Disease

Newborn

Intraventricular Hemorrhage

Meningitis

Seizures

Sepsis

Hypoxic-Ischemic Encephalopathy

Prematurity

Errors Metabolism, Inborn

Brain Malformation

干预/治疗

Other: Brain monitoring using PBSF protocol

相

资格标准

有资格学习的性别	All
取样方式	Non-Probability Sample
接受健康志愿者	是
标准	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.

结果

主要结果指标

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

次要成果指标

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

关键词

gerstmann-straussler-scheinker disease

sepsis

hemorrhage

hypothermia

brain ischemia

seizures

heart arrest

抗真菌药

抽象

日期

状况或疾病

干预/治疗

相

资格标准

结果

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