Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study investigates the impact of different levels of anesthesia exposure on children's neurocognitive development and evaluates the concurrent validity of different methods that assess neurodevelopmental outcome.
The US Food and Drug Administration (FDA) recently released an official warning regarding the potentially harmful impact of repeated and prolonged (more than three hours) general anesthesia on the child's brain. The potential impact of anesthesia highlights the importance of remediating the need for repeated and prolonged surgery with accompanying anesthesia exposure in a time of cerebral vulnerability and if possible, delay exposure to avoid potentially preventable harm. Therefore, it is crucial to better understand the impact of (different durations and frequencies of) anesthesia exposure on neurodevelopment.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient group | Infant aged 12 months (± four weeks) with a history of general anesthesia exposure |
| |
| Healthy subject group | Infant aged 12 months (± four weeks) without a history of general anesthesia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eyetracker | Diagnostic Test | Eye-tracking is an objective, non-invasive method and particularly suited to assess neurodevelopmental outcome in infants. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Neurocognitive development as measured using eye-tracking metrics | Neurocognitive development as measured using eye-tracking metrics | At the age of 12 months (± four weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Conventional measures of neurocognitive development (Ages & Stages Questionnaire and Bayley Scales of Infant Development ) | Neurocognitive development as measured using the Ages & Stages Questionnaire and Bayley Scales of Infant Development | At the age of 12 months (± four weeks) |
| Total anesthesia time. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
At the outpatient clinic of the department of pediatric surgery, children (< 12 months old) who are scheduled for or already underwent a single short, long or repetitive general anesthesia will be identified by the (fellow) pediatric surgeon. Parents/caretakers will be asked to participate in this study by the (fellow) surgeon who will ask informed consent. Healthy controls exist of eligible acquaintances and children that will be recruited via child health care centres by a member of the research team
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sanne Maat, MD | Contact | 0031650100868 | s.c.maat@amsterdamumc.nl |
| Name | Affiliation | Role |
|---|---|---|
| J.P.M. Derikx, MD, PhD | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | Principal Investigator |
| J. Oosterlaan, Prof. | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Amsterdam UMC, locatie AMC | Recruiting | Amsterdam | North Holland | 1105AZ | Netherlands |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Ages & Stages questionnaire | Diagnostic Test | The Ages & Stages Questionnaire is a conventional instrument used to measure developmental outcome in infants. |
|
| Bayley Scale of Infant Development | Diagnostic Test | The Bayley Scale of Infant Development is a conventional instrument used to measure developmental outcome in infants. |
|
Surgery and anesthesia time will be recorded by the (fellow) surgeon performing the operation(s). When multiple procedures are carried out, durations will be combined and these results will be retrieved during analysis of the data. |
| At the age of 12 months (± four weeks) |