Behavioral Assessment of Operated Preschool Children

Anesthesia Clinical Trial

— BASIS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04034654
• Other study ID #: P1-BE-2
• Status: Completed
• Start date: February 1, 2019
• Est. completion date: May 30, 2019

Study information

• Verified date: July 2019
• Source: Lithuanian University of Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: May 30, 2019
• Est. primary completion date: May 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Months to 5 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia
• Child Behavior
• Peri-operative Injury

Intervention

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.

Locations

Country	Name	City	State
Lithuania	Lithuanian University of Health Sciences	Kaunas

Sponsors (1)

Lead Sponsor	Collaborator
Lithuanian University of Health Sciences

Country where clinical trial is conducted

Lithuania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	abnormal behavioral outcome as assessed by CBCL	the number of children with one or more abnormal behavioral domains	2 to 5 year after surgery