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Behavioral Assessment of Operated Preschool Children

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04034654
Acronym
BASIS
Enrollment
37
Registered
2019-07-26
Start date
2019-02-01
Completion date
2019-05-30
Last updated
2019-07-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia, Child Behavior, Peri-operative Injury

Keywords

preschool child, behavior, anesthesia, surgery

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.

Interventions

OTHERQuestionaire

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.

Sponsors

Lithuanian University of Health Sciences
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Months to 5 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
abnormal behavioral outcome as assessed by CBCL2 to 5 year after surgerythe number of children with one or more abnormal behavioral domains

Countries

Lithuania

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026