Behavioral Assessment of Operated Preschool Children

Completed

• Conditions: Child Behavior; Anesthesia; Peri-operative Injury

• Registration Number: NCT04034654
• Lead Sponsor: Lithuanian University of Health Sciences

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 Timeline

• Study First Submitted: 2019-01-30
• Study Start: 2019-02-01
• Primary Completion: 2019-05-30
• Study Completion: 2019-05-30
• Status Verified: 2019-07
• Study First Submitted QC: 2019-07-24
• Last Update Submitted: 2019-07-24
• Study First Posted: 2019-07-26
• Last Update Posted: 2019-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
abnormal behavioral outcome as assessed by CBCL	2 to 5 year after surgery	the number of children with one or more abnormal behavioral domains

Trial Locations

Locations (1)

Lithuanian University of Health Sciences; 🇱🇹 Kaunas, Lithuania