First, to compare MLP children with FT and with EP peers regarding intelligence at age 14 to 15 years. Second, to compare MLP children with FT and with EP peers regarding health, health-related behaviors, growth measures, blood pressure, pubertal…
ID
Source
Brief title
Condition
- Other condition
- Neonatal and perinatal conditions
- Cognitive and attention disorders and disturbances
Synonym
Health condition
groei en ontwikkeling
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study endpoint will be the total IQ measured by the Wechsler Intelligence
Scale for Children-Third Edition-Dutch Version (WISC-III-NL), with subdivision
into verbal and performance IQ, for MLP compared to FT and EP children.
Secondary outcome
Secondary outcomes regard neuropsychological development measured by a series
of tests and questionnaires, pubertal development measured by assessment and
questionnaire, anthropometry by assessment, and reported health-related
behaviors, health literacy, social relations, time spending, school
performance, pain perception, and perceived health.
Background summary
Evidence lacks regarding intelligence, growth, and neurodevelopment at
adolescence of moderate and late preterm-born (gestational age 32-36 weeks,
MLP) children compared to early preterm (gestational age < 32 weeks, EP) and
full term (FT) children. There is increasing evidence for a link between fetal
and early neonatal life exposures such as preterm birth and /or low birth
weight and long-term outcomes on growth, development and health, supposedly due
to fetal and early neonatal reprogramming of neuroendocrine systems. This may
lead to a variety of different conditions, such as lower intelligence and
persistent neurodevelopmental disability, changes in growth patterns and in
pubertal development, lower educational achievement, and psychological
disturbances, also affecting the children*s social relations. Health-related
behaviors of preterm-born adolescents may also be affected, but evidence
regarding this completely lacks.
This project is a continuation of an existing cohort study running for more
than 10 years now. Earlier we showed in this cohort that both growth and
development of MLP children was delayed compared to FT children, but not as
much as that of EP children. This study will increase our knowledge on outcomes
of preterm-born children at adolescence, regarding intelligence, growth,
neuropsychological development, pubertal development, and social and
health-related behaviors. Our hypothesis is that prematurity is associated with
several of these outcome measures. Knowledge on this may lead to a better
understanding of risk factors, with the possibility of early and targeted
intervention, and better counselling of preterm-born adolescents and their
parents.
Study objective
First, to compare MLP children with FT and with EP peers regarding intelligence
at age 14 to 15 years. Second, to compare MLP children with FT and with EP
peers regarding health, health-related behaviors, growth measures, blood
pressure, pubertal development, and neuropsychological development including
executive functioning, attention, visual perception, and behavior in
adolescence. Third, to identify risk factors additional to prematurity that are
associated with these outcomes in adolescence.
Study design
Observational longitudinal cohort study
Study burden and risks
We will invite the children to come once to the research site. During that
visit with a total time-span of 3 to maximal 3.5 hours including instructions
and two short breaks of 15 minutes:
- Neuropsychological tests will be performed for intelligence, attention,
executive functioning, information processing and visual perception
- A limited physical examination will be performed, including measurements of
weight, length, head, waist and upper arm circumferences, blood pressure, and
percentage body fat. For estimating body fat percentage Bioelectrical Impedance
Analysis (BIA) will be used. Pubertal development will be assessed by the
adolescent children with vignettes according to Tanner stages, and the boys
will self-assess their testicular volume.
- A questionnaire will be filled in by the children on pubertal development,
social and health-related behaviors, time spending, perceived health, behavior,
perceived health and school performance.
- Parents will be asked to fill in questionnaires on the behavior and executive
functioning of their child, and a general questionnaire regarding socioeconomic
status (SES), family composition, major life-events in the family of the child,
medical history of the child, school performance, perceived health and
pain-perception of the child, and maternal and paternal factors such as
hypertension, height and weight.
Hanzeplein 1
Groningen 9713 GZ
NL
Hanzeplein 1
Groningen 9713 GZ
NL
Listed location countries
Age
Inclusion criteria
- member of the existing Pinkeltje (LOLLIPOP) cohort
- born in the three Northern provinces of the Netherlands;
- written informed consent from the child and both parents.
Exclusion criteria
none
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 |
---|---|
ISRCTN | ISRCTN80622320 |
CCMO | NL60329.042.16 |