Behavioral Assessment of Preschool Children Who Had Undergone General Surgery in Early Infancy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 37
- Locations
- 1
- Primary Endpoint
- abnormal behavioral outcome as assessed by CBCL
Study Overview
Brief Summary
This study will investigate the behavior of preschool children who had undergone general surgery during early infancy and will correlate the behavioral outcomes with clinical perioperative variables.
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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Months to 5 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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
Secondary Outcomes
No secondary outcomes reported
Investigators
Danguole C Rugyte
Professor, MD PhD
Lithuanian University of Health Sciences