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Cerebral Oxymetry and Neuronal Markers in Newborns and Infants Undergoing Surgery

NCT ID: NCT02423369

Last Updated: 2015-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2015-11-30

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.

Conditions

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Peri-operative Injury Newborn, Infant, Disease

Keywords

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S-100B protein Neuron-specific Enolase

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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neonates and infants requiring surgery

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.

Group Type EXPERIMENTAL

Cerebral near infrared spectroscopy

Intervention Type 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.

S-100B protein in serum

Intervention Type OTHER

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

NSE protein in serum

Intervention Type OTHER

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

Interventions

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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.

Intervention Type PROCEDURE

S-100B protein in serum

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

Intervention Type OTHER

NSE protein in serum

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

Intervention Type OTHER

Other Intervention Names

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cerebral tissue oxygen saturation cerebral oxymetry S-100B protein in blood Neuron-specific Enolase in blood

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.
Maximum Eligible Age

93 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Research Council of Lithuania

OTHER

Sponsor Role collaborator

Lithuanian University of Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Danguole C Rugyte

MD, PhD.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Danguole C Rugyte, MD. PhD

Role: PRINCIPAL_INVESTIGATOR

Lithuanian University of Health Sciences

Locations

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Lithuanian University of Health Sciences Kaunas Clinics

Kaunas, , Lithuania

Site Status

Countries

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Lithuania

References

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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.

Reference Type BACKGROUND
PMID: 20016413 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15680045 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20036866 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17880365 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10792747 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27793105 (View on PubMed)

Other Identifiers

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BE-2-43

Identifier Type: -

Identifier Source: org_study_id