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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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21 December 2015 |
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Main ID: |
NCT02423369 |
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Date of registration:
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17/04/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Cerebral Oxymetry and Neuronal Markers in Newborns and Infants Undergoing Surgery
NEMARKO |
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Scientific title:
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Cerebral Oxymetry and Neuronal Biomarkers in Newborns and Infants During Perioperative Period |
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Date of first enrolment:
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March 2013 |
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Target sample size:
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49 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02423369 |
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Study type:
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Interventional |
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Study design:
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Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening
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Phase:
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N/A
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Countries of recruitment
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Lithuania
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Contacts
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Name:
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Danguole C Rugyte, MD. PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Lithuanian University of Health Sciences |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- patients, undergoing general, thoracic, urological surgery for congenital anomalies
or disease
- signed written informed consent by parents/official caregivers
Exclusion Criteria:
- cardiac surgery
- any evidence of neurological disease
- sepsis
- limited ability to obtain blood samples
- clinically significant anemia
- physical status of the patients corresponding to American Society of
Anesthesiologists (ASA) class 4 and 5.
Age minimum:
N/A
Age maximum:
93 Days
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Newborn, Infant, Disease
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Peri-operative Injury
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Intervention(s)
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Other: S-100B protein in serum
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Other: NSE protein in serum
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Procedure: Cerebral near infrared spectroscopy
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Primary Outcome(s)
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change in S-100B and NSE concentrations in serum
[Time Frame: within 24 hours and 3 days after surgery]
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Secondary Outcome(s)
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association of S-100B and NSE concentrations in serum with intraoperative cerebral near infrared spectroscopy values.
[Time Frame: within 24 hours after surgery]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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