Peri-operative InjuryNEMARKONCT02423369
Cerebral Oxymetry and Neuronal Markers in Newborns and Infants Undergoing Surgery
A study testing Cerebral near infrared spectroscopy, S-100B protein in serum and NSE protein in serum in people with Peri-operative Injury and Newborn, Infant, Disease, run by Lithuanian University of Health Sciences at 1 site in Lithuania.
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. Read more about this study
- Who is it for?
- Ages Up to 93 days
- Conditions the study is for
- Peri-operative Injury, Newborn, Infant, Disease
- What is being tested?
- Cerebral near infrared spectroscopy, S-100B protein in serum and NSE protein in serum
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteLithuania
- Study dates
- Mar 2013to Nov 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 93 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- patients, undergoing general, thoracic, urological surgery for congenital anomalies or disease
- signed written informed consent by parents/official caregivers
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Lithuania1 site
Lithuanian University of Health Sciences Kaunas Clinics
Kaunas, 50009
About this study
Official title: Cerebral Oxymetry and Neuronal Biomarkers in Newborns and Infants During Perioperative Period
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.
Read the 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.
- Conditions
- Peri-operative Injury, Newborn, Infant, Disease
- Being tested
- Cerebral near infrared spectroscopy, S-100B protein in serum, NSE protein in serum
- Keywords
- S-100B protein, Neuron-specific Enolase
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cerebral near infrared spectroscopyProcedure or surgery
Also called cerebral tissue oxygen saturation, cerebral oxymetry
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 serumOther
Also called S-100B protein in blood
0,5-1 ml of blood from periferal site for determination of serum S-100B concentration.
NSE protein in serumOther
Also called Neuron-specific Enolase in blood
0,5-1 ml of blood from periferal site for determination of serum NSE concentration.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Cerebral near infrared spectroscopy; Other: S-100B protein in serum; Other: NSE protein in serum |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in S-100B and NSE concentrations in serum
change in S-100B and NSE concentrations in serum compared to preoperative value
Measured: 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.
Measured: within 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2015 (estimated)
- Study startMar 2013
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Peri-operative InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lithuanian University of Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Research Council of Lithuania
- Responsible party
- Principal investigator, Danguole C Rugyte, Lithuanian University of Health Sciences
- Investigators
- Danguole C Rugyte, MD. PhD, Principal investigator, Lithuanian University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02423369
- Sponsor's protocol ID
- BE-2-43
- Acronym
- NEMARKO
- Status last verified
- Dec 2015
- First submitted
- 17 Apr 2015
- Last updated
- 15 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 20016413Robertson 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.
PubMed 15680045Tina 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.
PubMed 20036866Vicente 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.
PubMed 17880365Jensen 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.
PubMed 10792747Razlevice 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.
PubMed 27793105
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerebral Oxymetry and Neuronal Biomarkers in Newborns and Infants During Perioperative Period
- ClinicalTrials.gov ID
- NCT02423369
- Acronym / sponsor ID
- NEMARKO / BE-2-43
- Conditions
- Peri-operative Injury, Newborn, Infant, Disease
- Keywords
- S-100B protein, Neuron-specific Enolase
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Lithuanian University of Health SciencesUniversity, hospital or other
- Collaborators
- Research Council of Lithuania
- Study start
- Mar 2013
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 22 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| neonates and infants requiring surgery | Experimental | Procedure: Cerebral near infrared spectroscopy, Other: S-100B protein in serum, Other: NSE protein in serumneonates 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. |
Who may qualify
- Ages
- Up to 93 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- patients, undergoing general, thoracic, urological surgery for congenital anomalies or disease
- signed written informed consent by parents/official caregivers
Key exclusion criteria (6 listed)
- cardiac surgery
- any evidence of neurological disease
- sepsis
- limited ability to obtain blood samples
- clinically significant anemia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cerebral near infrared spectroscopyAlso: cerebral tissue oxygen saturation, cerebral oxymetryAt the start of anesthesia on the patient's forehead two electrodes are attached the for continuous measurement of cerebral near infrared spectroscopy during surgery. | Procedure or surgery | neonates and infants requiring surgery |
| S-100B protein in serumAlso: S-100B protein in blood0,5-1 ml of blood from periferal site for determination of serum S-100B concentration. | Other | neonates and infants requiring surgery |
| NSE protein in serumAlso: Neuron-specific Enolase in blood0,5-1 ml of blood from periferal site for determination of serum NSE concentration. | Other | neonates and infants requiring surgery |
Primary outcome
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
1 secondary outcome
association of S-100B and NSE concentrations in serum with intraoperative cerebral near infrared spectroscopy values.
Time frame: within 24 hours after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2015.
- Background: PubMed 20016413Wang 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.
- Background: PubMed 15680045Robertson 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.
- Background: PubMed 20036866Tina 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.
- Background: PubMed 17880365Vicente 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.
- Background: PubMed 10792747Jensen 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.
- Derived from this study: PubMed 27793105Razlevice 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Danguole C Rugyte, MD. PhD principal investigator
Lithuanian University of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cerebral near infrared spectroscopy, S-100B protein in serum and NSE protein in serum in people with Peri-operative Injury and Newborn, Infant, Disease, run by Lithuanian University of Health Sciences at 1 site in Lithuania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lithuania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in S-100B and NSE concentrations in serum (time frame: within 24 hours and 3 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02423369, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2015; AzTrials last refreshed its copy on 7 Nov 2026.