Behavioral Assessment of Operated Preschool Children

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

37 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-02-01

Study Completion Date

2019-05-30

Brief Summary

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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.

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Detailed Description

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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

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Child Behavior Anesthesia Peri-operative Injury

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type OTHER

Other Intervention Names

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Child behavior checklist

Eligibility Criteria

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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

Minimum Eligible Age

18 Months

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No