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Completed

NCT Number: NCT04034654

Behavioral Assessment of Operated Preschool Children

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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Key information

Age range

18 month–5 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Lithuanian University of Health Sciences

Kaunas, LT44307, Lithuania

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Child behavior checklist

Primary outcomes

  1. abnormal behavioral outcome as assessed by CBCL

    Time frame: 2 to 5 year after surgery

    the number of children with one or more abnormal behavioral domains

Sponsors and collaborators

Lead sponsor

Lithuanian University of Health Sciences

Other

Registry information

Official study title

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

Acronym: BASIS

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jul 26, 2019
Registry last updated
Jul 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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