Cerebral Oxymetry and Neuronal Markers in Newborns and Infants Undergoing Surgery

NCT02423369 | Completed

• 1 other identifier: BE-2-43
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

Peri-operative Injury; Newborn, Infant, Disease

Keywords

S-100B protein; Neuron-specific Enolase

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• association of S-100B and NSE concentrations in serum with intraoperative cerebral near infrared spectroscopy values.

  within 24 hours after surgery

Other Outcomes (1)

• association of S-100B and NSE concentrations in serum with cumulative doses of sedative agents

  within 24 hours pre surgery to 3 days after surgery

Study Arms (1)

neonates and infants requiring surgery

EXPERIMENTAL

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; Other: S-100B protein in serum; Other: NSE protein in serum

Interventions

Cerebral near infrared spectroscopy PROCEDURE

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.

Also known as: cerebral tissue oxygen saturation, cerebral oxymetry

neonates and infants requiring surgery

S-100B protein in serum OTHER

0,5-1 ml of blood from periferal site for determination of serum S-100B concentration.

Also known as: S-100B protein in blood

neonates and infants requiring surgery

NSE protein in serum OTHER

0,5-1 ml of blood from periferal site for determination of serum NSE concentration.

Also known as: Neuron-specific Enolase in blood

neonates and infants requiring surgery

Eligibility Criteria

• Age: Up to 93 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• patients, undergoing general, thoracic, urological surgery for congenital anomalies or disease
• signed written informed consent by parents/official caregivers

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lithuanian University of Health Sciences: lead
• Research Council of Lithuania: collaborator

Study Sites (1)

Lithuanian University of Health Sciences Kaunas Clinics

Kaunas, 50009, Lithuania

Location

Related Publications (6)

• 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.

  PMID: 20016413 BACKGROUND

• 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. doi: 10.1017/S104795110400407X.

  PMID: 15680045 BACKGROUND

• 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(1):159-64. doi: 10.2741/e78.

  PMID: 20036866 BACKGROUND

• Vicente E, Tramontina F, Leite MC, Nardin P, Silva M, Karkow AR, Adolf R, Lucion AB, Netto CA, Gottfried C, Goncalves CA. S100B levels in the cerebrospinal fluid of rats are sex and anaesthetic dependent. Clin Exp Pharmacol Physiol. 2007 Nov;34(11):1126-30. doi: 10.1111/j.1440-1681.2007.04687.x.

  PMID: 17880365 BACKGROUND

• Jensen E, Sandstrom K, Andreasson 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. doi: 10.1046/j.1460-9592.2000.00522.x.

  PMID: 10792747 BACKGROUND

• Razlevice I, Rugyte DC, Strumylaite L, Macas A. Assessment of risk factors for cerebral oxygen desaturation during neonatal and infant general anesthesia: an observational, prospective study. BMC Anesthesiol. 2016 Oct 28;16(1):107. doi: 10.1186/s12871-016-0274-2.

  PMID: 27793105 DERIVED

MeSH Terms

Conditions

Disease

Interventions

S100 Calcium Binding Protein beta Subunit; Blood Specimen Collection; Phosphopyruvate Hydratase

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

S100 Proteins; Calcium-Binding Proteins; Carrier Proteins; Proteins; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Hydro-Lyases; Carbon-Oxygen Lyases; Lyases; Enzymes; Enzymes and Coenzymes

Study Officials

• Danguole C Rugyte, MD. PhD

  Lithuanian University of Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD.

Study Record Dates

• First Submitted: April 17, 2015
• First Posted: April 22, 2015
• Study Start: March 1, 2013
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: December 15, 2015

Record last verified: 2015-12

Locations

LI (1)