Cerebral Oxymetry and Neuronal Markers in Newborns and Infants Undergoing Surgery

Study Overview
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Brief Summary
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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.

Detailed Description
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Retrospective studies have shown that surgery in infancy is associated with worse neurodevelopmental outcome, compared to general population. The reasons may be complex, and patients at risk are unknown. Brain growth and central nervous system formation are extremely active in neonates and infants. Metabolic or circulatory derangement may have negative influence on the developing brain. Disease and perioperative period, both may further put this population at risk for physiological abnormalities. Near infrared spectroscopy was shown to be a convenient method for monitoring of cerebral tissue oxygenation during surgery. The great majority of anesthetics and sedative drugs, used in perioperative period, were shown to cause neuronal apoptosis in experimental animals. Some studies found that neurological marker S-100B increased in cerebrospinal fluid and blood immediately following anesthesia in animals. Several clinical studies supported this founding in children following cardiac and general surgery. The aim of this study is to assess the dynamics of S-100B protein pre- and during 72 hours after surgery in neonates and infants aged 1-93 days, operated for abdominal/thoracic/urologic malformations/disease. As S-100B in blood may have extracranial sources, we simultaneously assess other neuronal marker Neuron-specific Enolase.

Official Title
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Cerebral Oxymetry and Neuronal Biomarkers in Newborns and Infants During Perioperative Period

Conditions
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Peri-operative Injury, Newborn, Infant, Disease

Intervention / Treatment
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* Procedure: Cerebral near infrared spectroscopy
* Other: S-100B protein in serum
* Other: NSE protein in serum


Participation Criteria
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Eligibility 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.

Ages Eligible for Study
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Maximum Age: 93 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: neonates and infants requiring surgery<br>neonates and infants in whom blood samples for measurement of S-100 B protein in serum and NSE protein in serum are taken pre-operatively and 1-st, 2-nd and 3-rd post-operatively. During anesthesia cerebral near infrared spectroscopy is continuously applied until the wound closure. | Procedure: Cerebral near infrared spectroscopy<br>* 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.<br>* Other names: cerebral oxymetry;Other: S-100B protein in serum<br>* 0,5-1 ml of blood from periferal site for determination of serum S-100B concentration.<br>* Other names: S-100B protein in blood;Other: NSE protein in serum<br>* 0,5-1 ml of blood from periferal site for determination of serum NSE concentration.<br>* Other names: Neuron-specific Enolase in blood;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in S-100B and NSE concentrations in serum | change in S-100B and NSE concentrations in serum compared to preoperative value | within 24 hours and 3 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| association of S-100B and NSE concentrations in serum with intraoperative cerebral near infrared spectroscopy values. |  | within 24 hours after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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S-100B protein, Neuron-specific Enolase