To improve prediction of neurological and functional outcome at school age in infants at high risk of cerebral palsy.
ID
Source
Brief title
Condition
- Congenital and peripartum neurological conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Vineland-II
For the study of the kneejerk with the control group: the latency to the phasic
response to the kneen jerk
Secondary outcome
Neurological, motor, visual, cognitive and behavioural outcome
Background summary
Cerebral Palsy (CP) is one of the most common neurological disorders in
childhood, with a Western European incidence above 2 per 1000 live births.
Early identification of infants at risk of CP is desirable in order to provide
early intervention, in a phase when the brain is most plastic, and for family
counselling. We recently reported associations between both atypical pupillary
light responses and knee jerk responses in infancy and neurological outcome at
21 months corrected age in infants at high risk for CP. As the brain continues
to develop throughout childhood, associations between early risk factors and
later outcome may change with age. This means that associations between risk
factors and developmental outcome at early age may disappear when the child
grows older. But also the reverse may occur: associations between early risk
factors and developmental outcome may get stronger as dysfunctions may emerge
when the brain develops new functions. The latter occurs often in high-risk
infants. The aim of the present study is therefore to determine whether
neurological signs in infancy, such as an atypical pupillary light response and
atypical knee jerk responses are related to neurological and functional outcome
at school age.
For the amendment: the first data of the follow-up study indicate that the
responses to the kneejerk are not only deviant in children with CP (which has
been described in the literature), but proabably also in the children with an
early lesion of the brain without CP (which would be a novel finding). In order
to be able to describe and explain such findings we extend the knee-jerk part
of the study with a group of 25 typically developing peers (7-10 years of age)
without an early lesion of the brain.
Study objective
To improve prediction of neurological and functional outcome at school age in
infants at high risk of cerebral palsy.
Study design
Cohort study
Study burden and risks
The children will be assessed once. The assessment will take place at the
child*s home and the tests applied are child friendly. If the child - for
whatever reason - does not wish to cooperate anymore, the assessment is
stopped. It is discussed with the parents whether it is possible to reschedule
the appointment at a later point in time. To minimize the assessment time and
burden for the children, parents will also fill in questionnaires about their
child*s functioning. The benefit of the study is improving early prediction of
developmental outcome in high-risk infants. The data can only be obtained by
studying these high-risk infants. Benefits of participation for child and
family consist of getting detailed information on the child*s current
developmental status - if desired.
Control group: the assessment takes about 45 minutes. The parents fill out a
short questionnaire (10 minutes).
Hanzeplein 1
Groningen 9713 GZ
NL
Hanzeplein 1
Groningen 9713 GZ
NL
Listed location countries
Age
Inclusion criteria
For the patients: participation in the LEARN2MOVE 0-2years project (L2M; n=43).
Inclusion criteria for the original LEARN2MOVE 0-2 years project were age zero
to nine months CA at enrolment and the presence of at least one of the
following conditions:
(1) cystic periventricular leukomalacia,
(2) parenchymal lesion of the brain,
(3) severe neonatal hypoxic-ischaemic encephalopathy with brain lesions on MRI,
(4) neurological dysfunctions suggestive of the development of CP.
For the control group:
(1) typically developing
(2) age 7-10 years
(3) attending mainstream education
Exclusion criteria
For the patients: Exclusion criteria of the LEARN2MOVE 0-2 years project were:
- Children with severe congenital disorders
- Caregivers having insufficient understanding of the Dutch language
For the controls:
- presence of a complicated neonatal history
- presence of a neurodevelopmental disorder, such as cerebral palsy,
developmental coordination disorder, autism spectrum disorder, learning
disability, or attention deficit hyperactivity disorder
- Presence of the complex form of minor neurological dysfunction (MND)
- Caregivers having insufficient understanding of the Dutch language
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 | NL61985.042.17 |