Bijwerkingen centraal zenuwstelstel
Conditions
Interventions
None listed
Sponsors
Medisch Centrum Haaglanden
Eligibility
Age
2 Years to 17 Years
Inclusion criteria
Inclusion criteria: Healthy 6 to 16 year old volunteers, requiring an objective refraction because of standard departmental protocol, without syndromes or diseases or behaviour and/or attention syndromes (e.g. ADHD or ADD or autism spectral conditions etc.) and possessing a normal or low BMI. ;High BMI is defined in girls as having a BMI higher than 17.33 at 6 years of age, 17.74 at 7 years of age, 18.34 at 8 years of age, 19.06 at 9 years of age, 19.85 at 10 years of age, 20.73 at 11 years of age, 21.67 at 12 years of age, 22.57 at 13 years of age, 23.33 at 14 years of age, 23.93 at 15 years of age en 24.36 at 16 years of age (see page 27 of the protocol). For boys high BMI is defines as having a BMI higher than 17.54 at 6 years of age, 17.91 at 7 years of age, 18.43 at 8 years of age, 19.09 at 9 years of age, 19.83 at 10 years of age, 20.54 at 11 years of age, 21.21 at 12 years of age, 22.90 at 13 years of age, 22.61 at 14 years of age, 23.28 at 15 years of age en 23.89 at 16 years of age (see page 27 of the protocol).;Low BMI is defined in girls as having a BMI lower than 13.93 at 6 years of age, 14.01 at 7 years of age, 14.17 at 8 years of age, 14.43 at 9 years of age, 14.78 at 10 years of age, 15.26 at 11 years of age, 15.84 at 12 years of age, 16.44 at 13 years of age, 17.02 at 14 years of age, 17.53 at 15 years of age en 17.96 at 16 years of age (see page 27 of the protocol). For boys, low BMI is defined as having a BMI lower than 14.04 at 6 years of age, 14.07 at 7 years of age, 14.21 at 8 years of age, 14.42 at 9 years of age, 14.70 at 10 years of age, 15.04 at 11 years of age, 15.48 at 12 years of age, 15.99 at 13 years of age, 16.55 at 14 years of age, 17.14 at 15 years of age en 17.71 at 16 years of age (see page 27 of the protocol).
Exclusion criteria
Exclusion criteria: All subjects that do not meet the inclusion criteria described in D4a
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome is to detect the presence of EEG pattern changes after administration of 2 drops of cyclopentolate 1%. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes are the kind of EEG pattern changes, detection of time of onset of EEG pattern changes, detection of the amount and depth of EEG pattern changes and detect factors that influences onset of- and/or changes in EEG pattern. Furthermore detection of ECG changes and time of onset of these ECG changes. | — |
Countries
Netherlands
Outcome results
None listed