The primary aim of the current study is to investigate the test-retest reliability of background EEG, ERP and eye tracking measurements in specific tasks in infants of 10 months old. This will provide important general information for interpretation…
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Brief title
Condition
- Other condition
Synonym
Health condition
n.v.t.
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Our evaluation of the test-retest reliability of measures of brain development
will be based on the following outcomes:
- ERP peaks related to face processing in infants, specifically the amplitude
and latency of the so-called N290 peak, in response to photographs of faces
with different emotional expressions (emotional face task).
- Background EEG, as reflected in power in specific frequency bands in the EEG,
especially gamma power, to social and nonsocial film videos (background EEG
task)
- Length and number of visual fixations to stimuli that test different stages
of attention (gap/overlap task).
Secondary outcome
None
Background summary
Electroencephalogram (EEG) measurements (including Event Related Potentials, or
ERPs) in infants play a pivotal role in research on functional brain
development, because they can be used to measure, amongst others, emotional and
visual information processing in infants. In addition, eye tracking, which
provides information on eye movements of an infant, is increasingly used to
measure the focus and duration of attention of infants. Using these methods we
gradually gain insight in the functional development of the brain in the first
years of life. However, surprisingly little is known about the test-retest
reliability of EEG, ERPs, and eye tracking measurements in infants. Test-retest
reliability is an important property for measures used in developmental
studies, because it is crucial to know whether observed differences in these
measures at different time points are due to developmental changes or to
measurement error. Current knowledge of the reliability of EEG, ERP and eye
tracking measures is limited to adults and older children, and cannot simply be
extended to infants.
Study objective
The primary aim of the current study is to investigate the test-retest
reliability of background EEG, ERP and eye tracking measurements in specific
tasks in infants of 10 months old. This will provide important general
information for interpretation of studies on brain function in infants.
Study design
The study involves an observational non-invasive study including two testing
days in order to investigate the test-retest reliability of background EEG, ERP
and eye tracking measurements. The registration of EEG/ERP will be done using
an electrode cap and the registration of eye movements with aid of a special
camera. Furthermore, the interaction between the child and parent will be
observed and cognitive development will be assessed. We strive to test all
babies in the lab; but if parents indicate a preference for at-home testing, we
can adapt to that request and visit them at home with the testing equipment.
To obtain estimates of the test-retest reliability, we will invite the
children for the second, repeated measurement after maximally 2 weeks. We aim
to perform the complete measurements twice in 35 babies. As in practice,
between 50% and 67% of the measurements in infants succeeds (de Haan et al.,
2009), we will include a gross total of 75 infants. We will stop the inclusions
when we reach 35 successful measurements at both days.
Study burden and risks
This research is group-related because the study parameters are age-dependent.
Test-retest values are likely to differ between infants and older children or
adults.
There are no known risks associated with participation in the proposed research
and the burden is estimated to be moderate: a total course of 1,5 days at the
research center or 2 days at home, comprising approximately 180 minutes of
actual measuring time (twice 90 minutes). We emphasize that the actual
measuring time and task burden for the baby is NOT 1,5 or 2 days, but
approximately 90 minutes per testing day. We try to keep the burden for the
child as low as possible by adapting to the natural day-rhythm of the child and
leave ample time for rests and sleep. For that reason, we schedule a half to a
full day for 90 minutes of actual measurement.
The low burden for infant and parents can be concluded from a small parent
evaluation survey of a testing day.
An extensive evaluation of the burden experienced by parents and children in
this type of testing day is included in this study.
Heidelberglaan 1
Utrecht 3584CS
NL
Heidelberglaan 1
Utrecht 3584CS
NL
Listed location countries
Age
Inclusion criteria
• Age 10 months old (± 4 weeks; at time of testing)
• Born fullterm (>37)
Exclusion criteria
• Infant was premature (pre 37 weeks)
• Infant is looked after by the state (e.g. foster care), or other situation in which neither birth parent is involved in the infant*s care.
• Presence of known significant uncorrected vision or hearing impairment in infant (reported to parent by a doctor or health professional)
• Presence of known significant developmental or medical condition in infant likely to affect brain development or infant*s ability to participate in the study (e.g. Cerebral Palsy, Down*s syndrome, cystic fibrosis; reported to parent by a doctor or health professional)
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 | NL49099.041.14 |