Child BehaviorBASISNCT04034654
Behavioral Assessment of Operated Preschool Children
An observational study of Child Behavior and Anesthesia, run by Lithuanian University of Health Sciences at 1 site in Lithuania.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 months to 5 years
- Conditions the study is for
- Child Behavior, Anesthesia, Peri-operative Injury
- What is being tested?
- Questionaire
- How many people
- 37 participants
- Where
- 1 siteLithuania
- Study dates
- 1 Feb 2019to 30 May 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 months to 5 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Child Behavior, Anesthesia, Peri-operative Injury
- Being tested
- Questionaire
- Keywords
- preschool child, behavior, anesthesia, surgery
- Medical subject headings
- Child Behavior, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionaireOther
Also called Child behavior checklist
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
abnormal behavioral outcome as assessed by CBCL
the number of children with one or more abnormal behavioral domains
Measured: 2 to 5 year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2019
- Study start1 Feb 2019
- Primary completion30 May 2019
- Study completion30 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lithuanian University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Danguole C Rugyte, Lithuanian University of Health Sciences
- Investigators
- Danguole Rugyte, MD PhD, Principal investigator, Lithuanian University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04034654
- Sponsor's protocol ID
- P1-BE-2
- Acronym
- BASIS
- Status last verified
- Jul 2019
- First submitted
- 30 Jan 2019
- Last updated
- 26 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral Assessment of Preschool Children Who Had Undergone General Surgery in Early Infancy
- ClinicalTrials.gov ID
- NCT04034654
- Acronym / sponsor ID
- BASIS / P1-BE-2
- Conditions
- Child Behavior, Anesthesia, Peri-operative Injury
- Keywords
- preschool child, behavior, anesthesia, surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Lithuanian University of Health SciencesUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 30 May 2019 (actual)
- Study completion
- 30 May 2019 (actual)
- First posted
- 26 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 months to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionaireAlso: Child behavior checklistChild 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 | – |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Danguole Rugyte, MD PhD principal investigator
Lithuanian University of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Child Behavior and Anesthesia, run by Lithuanian University of Health Sciences at 1 site in Lithuania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lithuania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
abnormal behavioral outcome as assessed by CBCL (time frame: 2 to 5 year after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2019.