(1) Longitudinally describe the language and speech development in preterm children at 9 years of age. (2) Investigate whether these outcomes are related to a divergent development of neurological (language) system and (3) whether these language and…
ID
Source
Brief title
Condition
- Other condition
- Neonatal and perinatal conditions
Synonym
Health condition
language and speech development
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main outcome measure is the Core language score measured by the Clinical
Evaluation of Language Fundamentals-4 (CELF).
Secondary outcome
The secondary outcome measures are: receptive vocabulary (Peabody Picture
Vocabulary Test * PPVT); narrative ability (Renfrew Bus-story), functional
brain synchronisation (EERG/ERP), academic achievement (Cito-scores),
intelligence quotient (Wechsler Intelligence scale for children), complex
hearing (DDT), behaviour (Child Behaviour Checklist * CBCL), executive
functions (Behaviour Rating Inventory of Executive Function * BRIEF), the
competence experience of the child (Competence Experience Scale for Children *
CESC), intelligibility (Intelligibility in Context Scale * ICS), parent*s
satisfaction with the child*s communication in every-day communication
(VAS-scale and Children*s Communication Checklist - CCC-2); receptive
vocabulary of one of the parents (Peabody Picture Vocabulary Test * PPVT) and
quantifiable microstructural connectivity of both brain hemispheres using
advanced Magnetic Resonance Imaging (MRI) scan sequences (so called diffusion
tensor imaging sequences).
Background summary
Nowadays, one in ten children is born prematurely, which amounts to
approximately 500,000 preterm infants in Europe each year. Approximately 40% of
infants born at 24-32 weeks* gestational age show neurodevelopmental problems,
including problems in speech and language functions. Problems with complex
language functions seem to increase between the age of 3 to 13 years of age.
Since language is extremely important to academic achievement and communication
in everyday life, these results are important and alarming. The underlying
neural causes for these language problems are still not clear! Why does
language develop well in some ex-preterms, but not in others? Although
neuroimaging studies have shown some general structural and functional
differences in preterm compared to term-born children, longitudinal outcome
studies of (complex) language functions are lacking in this important patient
group. Knowledge is needed to understand the effects of preterm birth on
long-term language development.
Study objective
(1) Longitudinally describe the language and speech development in preterm
children at 9 years of age.
(2) Investigate whether these outcomes are related to a divergent development
of neurological (language) system and
(3) whether these language and neurological outcomes within the preterm-born
group somewhere along the trajectory (at age 2, 4 or 9 years) can predict
problems in academic achievement.
Study design
This study is a follow-up of the longitudinal cohort study of van Noort-van der
Spek [MEC-2012-149] and contains a single-centre longitudinal observational
cohort. 62 patients of the original study population of van Noort-van der Spek
were assessed at the age of 2 and 4 years of age and gave permission to contact
them for follow-up academic research. The primary caregivers will be invited to
participate in the recent study after informed consent. Parents and children
can participate by completing several questionnaires regarding behaviour,
executive functions, self-perception of the child, intelligibility and
communication in general. They will be asked to visit Erasmus MC-Sophia to test
simple and complex language and speech functions, peripheral and complex
hearing functions, brain activity and cognitive function. One of the parants
will be asked to do a receptive vocabulary test. The child*s teacher will be
asked to complete questionnaires concerning behaviour and executive functions
and provide scores of academic achievement (Cito-scores). After this visit
parents and child will be asked to participate in an optional additional second
visit to make a structural (advanced) MRI-scan of the brain of the child.
A group of matched term-born children will participate in only a subset of the
tests: ERP, hearing test, word comprehension test.
Study burden and risks
Burden for preterm children: The child*s behaviour, executive functions,
intelligibility and self-judgement is assessed by questionnaires for parents
(total of 45 minutes), teacher (total of 35 minutes) and/or the child itself
(15 minutes). In a first visit to the Erasmus MC-Sophia the complex language
function will be determined in approximately 90 minutes. ERP will be measured
by wearing an electrode cap (60 minutes). After lunch the IQ (60 minutes) and
hearing function (20 minutes) will be measured. During the IQ-test, the parent
will be doing the short receptive vocabulary test. In an optional second visit
a MRI-scan will be made (60 minutes).
Burden for term-born children: word comprehension test (10 minutes),
ERP-measurement (60 minutes), hearing test (20 minutes).
Burden participating parents of preterm-born children: word comprehension test
(10 minutes), the assessment will take place at the same time the child is
doing the IQ-test with the psychologist. This way, it will not cost the parent
and child extra time in the hospital.
Benefit and Risks: Collecting cognitive, language, speech and hearing scores
does not include any risks. Wearing the electrode cap for the purpose of
EEG/ERP neither includes any risks. The optional MRI-scan is also considered
very safe, since all standard procedures will be followed.
Dr. Molewaterplein 60
Rotterdam 3015 GJ
NL
Dr. Molewaterplein 60
Rotterdam 3015 GJ
NL
Listed location countries
Age
Inclusion criteria
For preterm subjects (N<=60): Children and their parents participated in the study by van Noort-van der Spek [MEC-2012-149], and parents gave permission to contact them in the future for scientific research, in their last contact moment.
One parent of each participating preterm child (N<=50): the parent that is accompanying the child at the day of testing has to give permission to participate in a language subtest himself/herself.;For term-born control children (N<=24): Children must be born at term age (>37 weeks of gestation) and an individual child must be matched to one of the preterm subjects with in respect to age, gender and education level of the mother.
Exclusion criteria
Participants (preterm-born and term-born) with a permanent (sensorineural) hearing loss from >20 dB at the best ear, measured with pure tone audiometry, will be excluded from participation.;Exclusion criteria for making the MRI scan in the optional additional visit are:
(1) Non-removable non-MRI compatible implants;
(2) Claustrophobia
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 | NL54905.078.15 |