NCT04034654

Behavioral Assessment of Operated Preschool Children

Behavioral Assessment of Preschool Children Who Had Undergone General Surgery in Early Infancy

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 37 (actual)
• Sponsor: Lithuanian University of Health Sciences · Academic / Other
• Sex: All
• Age: 18 Months – 5 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Child Behavior
• Anesthesia
• Peri-operative Injury

Interventions

Type	Name	Description
OTHER	Questionaire	Child behavior checklist is a questionaire, designed to evaluate 1.5-5 years old child's behavior. The checklist is filled out by parents/caregivers.

Timeline

• Start date: 2019-02-01
• Primary completion: 2019-05-30
• Completion: 2019-05-30
• First posted: 2019-07-26
• Last updated: 2019-07-26

Locations

1 site across 1 country: Lithuania