To examine cognition, motor function, executive functions, speech and language development, behaviour, psychosocial functioning, academic achievement, physical morbidities and growth of MLPTI at the age of 9 years and correlate this with BSID-III-NL…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Neonatologie, ontwikkeling, gedrag
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameters are the IQ-scores, motoric scores of the MABC,
executive functions of the EMMA Toolbox and speech- and language-developmental
scores of the CELF-5-NL and CCC-2-NL.
Secondary outcome
Secondary outcome parameters are CITO-scores, the behavioural and psychosocial
outcomes of the CBCL and the SDQ, the presence of morbidities, the growth
pattern and blood pressure. Other outcome parameters are the relation between
the 9-year outcomes and the BSID-III scores at the age of 2, and the
differences between the MLPTI and the control group. Furthermore, we aim to
determine the relation between growth and body composition in the first two
years of life and the waist circumference, growth parameters and blood pressure
at the age of 9 years.
Background summary
Recent studies indicate that moderate and late preterm infants (MLPTI,
gestational age (GA) 32-36 weeks) are at risk of lower IQ scores, behavioural
problems and attention disorders and decreased school performances at the age
of 6 to 10 years. One recent study correlated these attention problems at the
age of 6 with outcomes of the Bayley Scales of Infant and Toddler Development
(BSID-III-NL) performed at the age of 2. These recent findings are in contrast
with the long-thought theory that MLPTI have the same outcomes as full-term
children. Since the number of studies performed on this group is limited and
the developmental outcomes of MLPTI remains a subject of debate, more
prospective data are necessary to prove whether these children are truly at
risk of impaired outcomes. The study with this cohort performed at the age of 2
years did not find an impaired outcome on the BSID-III-NL scores. However, it
is questionable whether this test is sensitive enough to find small differences
and if problems are more obvious at school age. Furthermore, we should
investigate the possibility of early detection of these impaired outcomes.
Study objective
To examine cognition, motor function, executive functions, speech and language
development, behaviour, psychosocial functioning, academic achievement,
physical morbidities and growth of MLPTI at the age of 9 years and correlate
this with BSID-III-NL scores, growth parameters and body composition at the age
of 2 years.
Study design
This study will be a prospective open, non-therapeutic exploratory cohort study
and can be seen as a continuation on the study with protocol identification
number NL50800.094.14, performed in the NWZ Alkmaar between 2014 and 2016. This
was a study on growth and neurodevelopment of MLPTI in the first 2 years of
life.
Study burden and risks
The burden consist of coming to the outpatient clinic for one schoolday to
perform the aforementioned tests. The WISC-V, MABC and CBCL are part of
standard care in very and extreme preterm children (GA<32 weeks) at the age of
8, have no risks and are a minimal burden. The Emma Toolbox and CELF-5-NL are
not part of standard care, but also developmental tests with no risk and
minimal burden and are widely used in different international studies. The
tests performed during this visit will take up to four and a half hours in
total (including a break). There is also an additional burden for the parents,
since they will be asked to fill in questionnaires, which takes up to an hour
in total. This study cannot be performed in an adult group of patients, since
we explicitly want to explore these outcomes of MLPT at the age of 9.
Wilhelminalaan 12
Alkmaar 1815JD
NL
Wilhelminalaan 12
Alkmaar 1815JD
NL
Listed location countries
Age
Inclusion criteria
1. The participant is born in or transferred to the NWZ Alkmaar between January
1st, 2014 and April 18th, 2016 (the inclusion time of trial NL50800.094.14)
2. The participant born at a gestational age from 32 to 35+6 weeks
3. The participant received follow-up conform the trial with trial-number
NL50800.094.14
4. Both parents of the participant have given informed consent to participate
in this trial
OR (Control group)
1. The participant has a brother, sister or friend who meets aforementioned
inclusion criteria.
2. The participant is between 8 and 10 years old when participating in this
study.
3. The participant is a child that lives < 20 km of Alkmaar and is
recruited at the 9 years
vaccination of the GGD
4. The participant is related to an employee of the North West Hospital and
living < 20 km of
Alkmaar
5. The participant is not born preterm or admitted to a neonatology ward
post-partum and
Exclusion criteria
1. The participant*s parents are not able to fill out questionnaires or perform
tests in Dutch 2. The participant has a severe developmental disorder and is
thereby not able to perform the tests 3. The participant is not able to come to
the outpatient clinic to do the tests OR (Control Group) 1. The participant is
born with a GA < 37 weeks 2. The participant has a severe developmental
disorder and is thereby not able to perform the tests
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 | NL82197.029.22 |
| Other | Trialregister NTR 5563 |