No registrations found.
ID
Source
Brief title
Health condition
Surgeries related to dDuodenal-jejunal-ileal atresia repairs, anorectal malformation, Hirschsprung disease and/or inguinal hernia
Sponsors and support
Intervention
Outcome measures
Primary outcome
Neurocognitive development as measured using eye-tracking metrics
Secondary outcome
a. Conventional measures of neurocognitive development (Ages & Stages Questionnaire and Bayley Scales of Infant Development )
b. Total anesthesia time. 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.
Background summary
Recent evidence indicates that prolonged or repeated anesthesia threaten neurodevelopment. Therefore, we deem that it is crucial to assess the impact of different levels of anesthesia exposure between groups on neurodevelopmental outcome. For this prospective study, children with and without a history of general anesthesia exposure during pediatric surgery are recruited at the age of 12 months to measure neurodevelopment at the outpatient clinic using the Ages & Stages Questionnaire, the Bayley Scales of Infant Development and the Eye-tracking paradigms.
Study objective
Anesthesia exposure before the age of 12 months old has a negative impact on neurocognitive development.
Study design
Participation in this trial consists of one (extra) visit to the outpatient clinic. For most patients, this will be scheduled during their regular follow-up visit at 12 months (± four weeks) of age.
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all of the following criteria: age 12 months (± four weeks) with a history of general anesthesia exposure (patient group) or without a history of general anesthesia (healthy controls)
Exclusion criteria
Children with comorbid conditions affecting structure and/or function of the central nervous system (e.g. premature birth) will be excluded from participation in this study.
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL8937 |
| Other | METc Amsterdam UMC, location AMC : METC 2019_249 |