Cerebral Oxymetry and Neuronal Markers in Newborns and Infants Undergoing Surgery

Not Applicable

Completed

• Conditions: Peri-operative Injury; Newborn, Infant, Disease
• Interventions: Procedure: Cerebral near infrared spectroscopy; Other: S-100B protein in serum; Other: NSE protein in serum

• Registration Number: NCT02423369
• Lead Sponsor: Lithuanian University of Health Sciences

Brief 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.

Detailed Description

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.

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2015-04-17
• Study First Submitted QC: 2015-04-17
• Study First Posted: 2015-04-22
• Primary Completion: 2015-11
• Study Completion: 2015-11
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-12
• Last Update Posted: 2015-12-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
neonates and infants requiring surgery	NSE protein in serum	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.
neonates and infants requiring surgery	Cerebral near infrared spectroscopy	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.
neonates and infants requiring surgery	S-100B protein in serum	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.

Primary Outcome Measures

Name	Time	Method
change in S-100B and NSE concentrations in serum	within 24 hours and 3 days after surgery	change in S-100B and NSE concentrations in serum compared to preoperative value

Secondary Outcome Measures

Name	Time	Method
association of S-100B and NSE concentrations in serum with intraoperative cerebral near infrared spectroscopy values.	within 24 hours after surgery

Trial Locations

Locations (1)

Lithuanian University of Health Sciences Kaunas Clinics; 🇱🇹 Kaunas, Lithuania