The main objective is to assess long-term neurodevelopmental, cardiovascular, pulmonary, and growth outcomes in a cohort of MC twins with sFGR and to compare outcomes within sFGR twin pairs.
ID
Source
Brief title
Condition
- Myocardial disorders
- Foetal complications
- Cognitive and attention disorders and disturbances
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To assess long-term neurodevelopmental outcome, cognitive and motor development
will be evaluated using standardized psychometric age-appropriate tests and a
neurological examination. Echocardiography will be used to assess differences
in structural cardiac measures and cardiac function, including aortic
pulse-wave velocity (aPWV) and carotid intima-media thickness (cIMT).
Spirometry will be recorded in children >= 4 years old to quantify lung
function, including forced vital capacity (FVC), forced expiratory volume in
one second (FEV1) and forced mid-expiratory flow rate (FEF(25%-75%). Growth
will be assessed using available childhood growth curves from the primary care
system and by detailed anthropometric measurements.
Secondary outcome
The project addresses multiple secondary objectives that can be grouped into
the same five categories as the primary objectives:
I. Neurodevelopmental outcome
a) To describe the incidence of mild and severe NDI.
b) To identify potential risk factors within the sFGR population for low
cognitive test scores.
c) To evaluate long-term behavioral outcome, attachment, quality of life and
school functioning including academic performance.
II. Cardiovascular outcome
a) To assess within-pair differences in blood pressure.
III. Pulmonary outcome
a) To document within-pair differences in atopic constitution.
IV. Growth
a) To assess pubertal development.
b) To assess intra-twin growth patterns in the sFGR population.
V. (Epi)genetics
a) To describe epigenetic differences in peripheral tissue (buccal swabs) as a
possible underlying mechanism for the mediation of the long-term effects of
FGR. The specific DNA methylation patterns found in the Twinlife study will be
examined in the population of the current study as well to examine their link
with long-term outcomes.
Background summary
Selective fetal growth restriction (sFGR) in monochorionic (MC) twin
pregnancies is characterized by a large intertwin growth discrepancy due to
unequal placental sharing.
Neonatal morbidity and mortality associated with sFGR have been thoroughly
described, but data on long-term outcomes is lacking although we know that
fetal growth restriction (FGR) in singletons has been associated with an
increased risk of neurodevelopmental impairment (NDI), cardiovascular disease
(CVD), impaired lung function and suboptimal growth later in life.
Knowledge of long-term outcomes is essential both for adequate counselling of
parents of these vulnerable patients and for early identification of children
who will benefit from additional postnatal monitoring. Moreover, a better
understanding of long-term outcome might aid in devising feasible management
options in the future.
Therefore, insight into long-term outcomes is crucial in providing the highest
standard of care for MC twins with sFGR. The results of this study will be
complementary to the Twinlife study (NL67331.058.18) which is already ongoing
at the LUMC.
Study objective
The main objective is to assess long-term neurodevelopmental, cardiovascular,
pulmonary, and growth outcomes in a cohort of MC twins with sFGR and to compare
outcomes within sFGR twin pairs.
Study design
An observational cohort study.
Study burden and risks
The total duration of the participation for each child is approximately * day,
including the questionnaires and the assessments. The neurodevelopmental
assessment comprises approximately 2-3 hours of examination time and is
generally experienced as enjoyable for children. The echocardiography, blood
pressure measurement, aPWV measurement using the arteriograph constitutes 30-45
minutes per child. The growth measurements and buccal swabs will generally be
completed within 10 minutes per child. The spirometry will be performed in
approximately 30-45 minutes per child. Thus, the total burden is considered
minimal. Parents will be asked to fill in a total of six questionnaires
regarding background, health, school functioning, behaviour, attachment and
quality of life prior to and during the follow-up examination. Children >= 8
years of age will fill in a self-assessment on pubertal development stage. No
risk is associated with study participation. Participation does not result in
individual benefits.
albinusdreef 2
leiden 2333za
NL
albinusdreef 2
leiden 2333za
NL
Listed location countries
Age
Inclusion criteria
To be eligible to participate in this study, a subject must meet all the
following criteria:
• MC twins with sFGR born in the LUMC.
• Children aged 2 to 17 years at time of inclusion.
• Children currently living in the Netherlands.
The parents of a potential subject must meet the following criteria:
• Parent(s) aged >= 18 years, who are able to consent.
• Written informed consent from both parents to participate, form being
approved by the Ethic Committee.
When one of the parents has passed away, the surviving parent with parental
authority can provide informed consent. When both parents have passed,
guardians or caretakers with parental authority can provide informed consent.
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded
from participation in this study:
• MC twins with TTTS or TAPS.
• Twin Reversed Arterial Perfusion (TRAP).
• Monoamniotic twin pregnancies.
• Children passed away before inclusion.
• Single survivors.
• Children born with congenital/chromosomal abnormalities.
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
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 | NL75027.058.20 |