- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04034654
Behavioral Assessment of Operated Preschool Children (BASIS)
Behavioral Assessment of Preschool Children Who Had Undergone General Surgery in Early Infancy
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Several epidemiologic and observational studies found the relation between surgery in childhood and neurodevelopmental features in later life. However, these studies are criticized for retrospective design, non homogenous population, social confounders, diversity of surgical procedures and anesthetic management.
Monitoring of neurological function has become standard during surgical procedures at risk for neuronal injury (e.g. cardiac surgery). There is also some data on possible predictive value of certain methods of neuromonitoring (such as cerebral near infrared spectroscopy (NIRS)) for neurodevelopmental outcome.
General neonatal/infant surgery and the whole perioperative period carry the risk of significant physiologic disturbances, which may affect cerebral perfusion, oxygenation or metabolism. This study is the continuum of prospective observational trial, which investigated the value of the neuromonitoring measures in neonates and young infants undergoing general surgery. The present study will apply the behavioral assessment of these patients who are now between 2 and 5 years of age.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Kaunas, Lithuania, LT44307
- Lithuanian University of Health Sciences
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- children, who had undergone general surgery for congenital anomalies or disease from birth until 93 days of age at a single University hospital
- general anesthesia with inhalational anesthetic was applied during surgery
- artificial lung ventilation was applied during anesthesia
- NIRS values were recorded throughout anesthesia
- serum concentrations of brain specific proteins were obtained during perioperative period
Exclusion Criteria:
- children, who had undergone cardiac, neurosurgical, ear, nose and throat or eye surgery from birth until 93 days of age
- general anesthesia without tracheal intubation was applied
- local or combined local/general anesthesia was applied
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
abnormal behavioral outcome as assessed by CBCL
Time Frame: 2 to 5 year after surgery
|
the number of children with one or more abnormal behavioral domains
|
2 to 5 year after surgery
|
Collaborators and Investigators
Investigators
- Principal Investigator: Danguole Rugyte, MD PhD, Lithuanian University of Health Sciences
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- P1-BE-2
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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