To investigate the impact of different levels of anesthesia exposure on children*s neurocognitive development and evaluate the concurrent validity of different methods to assess neurodevelopmental outcome.
ID
Source
Brief title
Condition
- Neurological disorders NEC
- Therapeutic procedures and supportive care NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Neurodevelopmental outcome (infant development, motor and cognitive development
and early attention) in children with a history of anesthesia exposure before
the age of 12 months.
Secondary outcome
Concurrent, convergent and divergent validity of eye-tracking relative to
traditional measures (Ages & Stages Questionnaire and Bayley Scales of Infant
Development) of neurodevelopmental outcome in children with a history of
anesthesia exposure before the age of 12 months.
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. The Ages and Stages questionnaire and Bayley Scale are well-known and
widely used methods to accurately measure neurodevelopment, i.e. early global
motor and cognitive development. Eye tracking is eminently suitable to assess
early neurocognitive development, more specifically the infant*s early
attentional system which is of paramount importance for later cognitive
development.
Study objective
To investigate the impact of different levels of anesthesia exposure on
children*s neurocognitive development and evaluate the concurrent validity of
different methods to assess neurodevelopmental outcome.
Study design
Prospective observational study. Neurodevelopmental outcome will be assessed in
children with a history of different levels of anesthesia exposure before the
age of 12 months using the Ages & Stages Questionnaire, Bayley Scales of Infant
Development and eye-tracking metrics.
Study burden and risks
There are no additional risks associated with participation in this study and
the burden can be considered minimal. This study assesses whether anesthesia
exposure is harmful to children*s neurocognitive development. Therefore, this
study can only be performed in this group of minors.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
- Infants aged 12 months
- Anesthesia exposure before the age of 12 months
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
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 |
|---|---|
| CCMO | NL71873.018.19 |
| Other | volgt |