At a glance
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Cerebral Oxymetry and Neuronal Biomarkers in Newborns and Infants During Perioperative Period
In Brief
A clinical study evaluating Cerebral near infrared spectroscopy, S-100B protein in serum, and 1 other intervention for Peri-operative Injury and Newborn, Infant, Disease. Completed, enrolled 49 participants across 1 site.
Detailed Summary
The purpose of this study is to assess whether peri-operative period in neonates and infants is associated with an increase in blood biomarkers, specific for neuronal injury, and to correlate them with clinical variables and sedative/analgesic agents. Patients, who meet inclusion criteria and does not meet exclusion criteria, are enrolled. Blood samples for measurement serum concentrations of markers (S100-B and Neuron-Specific Enolase (NSE)) are drawn before surgery (baseline) and on the 1-st, 2-nd and 3-rd day after surgery. During surgery cerebral oxygenation (rSO2) monitoring is continuously applied; rSO2, hemodynamic and respiratory values are simultaneously recorded every 5 minutes. Anesthesia, pre and postoperative treatment, including analgesia and sedation, are given as per standard of care.
Study Details
Timeline
Interventions
At the start of anesthesia on the patient's forehead two electrodes are attached the for continuous measurement of cerebral near infrared spectroscopy during surgery.
0,5-1 ml of blood from periferal site for determination of serum S-100B concentration.
0,5-1 ml of blood from periferal site for determination of serum NSE concentration.