Cerebral Oxymetry and Neuronal Markers in Newborns and Infants Undergoing Surgery

Newborn, Infant, Disease Clinical Trial

— NEMARKO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02423369
• Other study ID #: BE-2-43
• Status: Completed
• Phase: N/A
• First received: April 17, 2015
• Last updated: December 12, 2015
• Start date: March 2013
• Est. completion date: November 2015

Study information

• Verified date: December 2015
• Source: Lithuanian University of Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Lithuania: Bioethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 93 Days

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• Newborn, Infant, Disease
• Peri-operative Injury

Intervention

Procedure:
• Cerebral near infrared spectroscopy
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.

Other:
• S-100B protein in serum
0,5-1 ml of blood from periferal site for determination of serum S-100B concentration.
• NSE protein in serum
0,5-1 ml of blood from periferal site for determination of serum NSE concentration.

Locations

Country	Name	City	State
Lithuania	Lithuanian University of Health Sciences Kaunas Clinics	Kaunas

Sponsors (2)

Lead Sponsor	Collaborator
Lithuanian University of Health Sciences	Research Council of Lithuania

Country where clinical trial is conducted

Lithuania, 

References & Publications (5)

Jensen E, Sandström K, Andréasson S, Nilsson K, Berggren H, Larsson LE. Increased levels of S-100 protein after cardiac surgery with cardiopulmonary bypass and general surgery in children. Paediatr Anaesth. 2000;10(3):297-302. — View Citation

Robertson DR, Justo RN, Burke CJ, Pohlner PG, Graham PL, Colditz PB. Perioperative predictors of developmental outcome following cardiac surgery in infancy. Cardiol Young. 2004 Aug;14(4):389-95. — View Citation

Tina LG, Frigiola A, Abella R, Tagliabue P, Ventura L, Paterlini G, Li Volti G, Pinzauti S, Florio P, Bellissima V, Minetti C, Gazzolo D. S100B protein and near infrared spectroscopy in preterm and term newborns. Front Biosci (Elite Ed). 2010 Jan 1;2:159-64. — View Citation

Vicente E, Tramontina F, Leite MC, Nardin P, Silva M, Karkow AR, Adolf R, Lucion AB, Netto CA, Gottfried C, Gonçalves CA. S100B levels in the cerebrospinal fluid of rats are sex and anaesthetic dependent. Clin Exp Pharmacol Physiol. 2007 Nov;34(11):1126-30. — View Citation

Wang S, Peretich K, Zhao Y, Liang G, Meng Q, Wei H. Anesthesia-induced neurodegeneration in fetal rat brains. Pediatr Res. 2009 Oct;66(4):435-40. doi: 10.1203/PDR.0b013e3181b3381b. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	association of S-100B and NSE concentrations in serum with cumulative doses of sedative agents	Pre and postoperative S-100B and NSE concentrations in serum will be correlated with the administered pre and postoperative cumulative doses of sedatives and analgesics	within 24 hours pre surgery to 3 days after surgery	No
Primary	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	No
Secondary	association of S-100B and NSE concentrations in serum with intraoperative cerebral near infrared spectroscopy values.		within 24 hours after surgery	No