Behavioral Assessment of Operated Preschool Children

NCT04034654 | Completed

• 1 other identifier: P1-BE-2
• Study Type: observational
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Child Behavior; Anesthesia; Peri-operative Injury

Keywords

preschool child; behavior; anesthesia; surgery

Outcome Measures

Primary Outcomes (1)

• abnormal behavioral outcome as assessed by CBCL

  the number of children with one or more abnormal behavioral domains

  2 to 5 year after surgery

Interventions

Questionaire OTHER

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.

Also known as: Child behavior checklist

Eligibility Criteria

• Age: 18 Months - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children, aged 1.5-5 years, who had undergone general abdominal, thoracic, genitourinary surgery until 93 days of life in a single University hospital and were given standard inhalational general anesthesia with tracheal intubation and measures for neuromonitoring such as cerebral NIRS and measurement of brain specific proteins during perioperative period was applied.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lithuanian University of Health Sciences: lead

Study Sites (1)

Lithuanian University of Health Sciences

Kaunas, LT44307, Lithuania

Location

MeSH Terms

Conditions

Child Behavior; Behavior

Study Officials

• Danguole Rugyte, MD PhD

  Lithuanian University of Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, MD PhD

Study Record Dates

• First Submitted: January 30, 2019
• First Posted: July 26, 2019
• Study Start: February 1, 2019
• Primary Completion: May 30, 2019
• Study Completion: May 30, 2019
• Last Updated: July 26, 2019

Record last verified: 2019-07

Locations

LI (1)