(1) investigate alterations in executive functioning in extremely preterm-born adolescents in the Netherlands relative to term-born controls, (2) assess the neurobiological basis of individual variability in executive functioning following preterm…
ID
Source
Brief title
Condition
- Structural brain disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main endpoints of the study are the CANTAB scores of executive functioning
(memory, attention, processing speed, cognitive flexibility, emotion
recognition, inhibition, visual and social processing) in the population of
exteme preterms at adolescent age.
Secondary outcome
- Quantative MRI analysis including structural, resting state functional
(fMRI), diffusion imaging (DTI).
- possible predictors for CANTAB scores at this age, including parental
education, TEA MRI, earlier developmental scores, gender, and early-life stress
(e.g.,prenatal data and stress during NICU stay).)
- possible predictors for abnormal MRI scores at this age, including parental
education, TEA MRI, earlier developmental scores, gender, and early-life stress
(e.g.,prenatal data and stress during NICU stay).)
- By post-hoc grouping of the variables into mixed effect models we hope to
identify multidimensional resilient and vulnerable groups within our population
, we will use variables in categories:
* Clinical factors: For example, the number of days the patient required
ventilation during their stay in the NICU, and the results of executive
function tests.
* Environmental factors: The socio-economic status (SES) of the parents.
* Social factors: The educational level of the parents, and the CANTAB test for
emotion recognition.
* Biological factors: Such as the structure of the brain in earlier MRI scans,
as well as sex differences that may play a role in the development of
resilience and vulnerability.
Background summary
Prematurity imposes a significant global health burden, affecting approximately
11% of all births worldwide and remains a leading cause of infant morbidity and
mortality . Long-term neurodevelopmental delays are prevalent among those born
extremely premature, with preterm children being more likely to develop
behavioural, attention, hyperactivity-impulsivity, and social-communication
difficulties than term-born children. Furthermore, structural alterations in
the brain, including reductions in various brain regions, are commonly
observed. Despite advancements in medical care leading to increased survival
rates, neurobehavioral outcomes among preterm infants have remained largely
unchanged or worsened over the past years, underscoring the need for a deeper
understanding of neurodevelopment in these neonates. Furthermore, it remains a
challenge to predict which infants are at risk or resilient for developing
maladaptive neurodevelopmental outcomes. Literature has shown that executive
functioning is essential in resilience and predicts neurocognitive functioning
better than IQ for example. Currently, follow-up programmes are designed until
the age of 8 years in the Netherlands [NVK], potentially leaving a knowledge
gap in neurocognitive functioning of older, extreme premature survivors in the
Netherlands. Especially since, we know that neurodevelopmental, social, and
emotional problems persist into adulthood and we know that adolescence poses
challenges in neurocognition.
Primarily, we focus on comparing executive functions between preterm and
full-term children, where cognitive performance is assessed without considering
the experienced stress.
The secondary outcome measure specifically focuses on the multidimensional
aspects of resilience and vulnerability. Through multidimensional constructs,
including biological, social, environmental, and clinical factors, we highlight
variations in functioning. Neurocognitive outcomes, as clinical factors,
contribute to the formation of either a resilient or vulnerable profile. These
neurocognitive performances can, for example, help predict how well children
cope with challenges related to premature birth.
Study objective
(1) investigate alterations in executive functioning in extremely preterm-born
adolescents in the Netherlands relative to term-born controls,
(2) assess the neurobiological basis of individual variability in executive
functioning following preterm birth,
(3) identify possible predictive factors for atypical executive functioning
(4) classify distinct behavioural, clinical, and environmental patterns of
resilience and vulnerability following preterm birth.
Study design
The study design is a prospective observational study, primarily
cross-sectional in nature, but with longitudinal data analysis as well. The
study is built up from two parts: an online executive assessment and a cerebral
MRI scan.
Study burden and risks
The study focuses on adolescents born extremely premature to understand
long-term executive functioning and brain networks, with minimal risks and
burdens. This study involves assessments of executive function conducted in a
safe home environment using an online test-battery, and a 30-minute cerebral
MRI without sedation or intravenous contrast. This age group is specifically
chosen as executive functioning challenges become more pronounced in
adolescence, providing a comprehensive understanding of the long-term impacts
of extreme prematurity on cognitive development. Furthermore, this age group
offers insight into adolescents born since the guideline of 2010, which permits
treatment from 24 weeks gestational age. There are no direct benefits to
participants, but findings could contribute to the understanding of
neurobehavioral outcomes for extremely preterm infants and improve personalized
care programs in the Netherlands.
Lundlaan 6
Utrecht 3584 EA
NL
Lundlaan 6
Utrecht 3584 EA
NL
Listed location countries
Age
Inclusion criteria
Gestational age <28 weeks
Born between January 2009 and December 2012
Exclusion criteria
Major chromosomal and/or congenital anomalies
Ferromagnetic implants
Claustrophobia
Parents who refuse to be informed about unexpected clinically relevant
information
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 | NL87035.041.24 |