Behavioral Assessment of Operated Preschool Children (BASIS)

July 24, 2019 updated by: Danguole C Rugyte, Lithuanian University of Health Sciences

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

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.

Study Overview

Status

Completed

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

37

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Kaunas, Lithuania, LT44307
        • Lithuanian University of Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 5 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
2 to 5 year after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Danguole Rugyte, MD PhD, Lithuanian University of Health Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2019

Primary Completion (Actual)

May 30, 2019

Study Completion (Actual)

May 30, 2019

Study Registration Dates

First Submitted

January 30, 2019

First Submitted That Met QC Criteria

July 24, 2019

First Posted (Actual)

July 26, 2019

Study Record Updates

Last Update Posted (Actual)

July 26, 2019

Last Update Submitted That Met QC Criteria

July 24, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • P1-BE-2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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