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Completed

NCT Number: NCT02423369

Cerebral Oxymetry and Neuronal Markers in Newborns and Infants Undergoing Surgery

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.

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Key information

Age range

Up to 93 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lithuanian University of Health Sciences Kaunas Clinics

Kaunas, 50009, Lithuania

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: cerebral tissue oxygen saturation, cerebral oxymetry

S-100B protein in serum

Other

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

Other names: S-100B protein in blood

NSE protein in serum

Other

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

Other names: Neuron-specific Enolase in blood

Primary outcomes

  1. change in S-100B and NSE concentrations in serum

    Time frame: within 24 hours and 3 days after surgery

    change in S-100B and NSE concentrations in serum compared to preoperative value

Secondary outcomes

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

    Time frame: within 24 hours after surgery

Other outcomes

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

    Time frame: within 24 hours pre surgery to 3 days after surgery

    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

Sponsors and collaborators

Lead sponsor

Lithuanian University of Health Sciences

Other

Collaborators

  • Research Council of Lithuania

Registry information

Official study title

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

Acronym: NEMARKO

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Apr 22, 2015
Registry last updated
Dec 15, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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