Primary objective: To determine whether the short-term neurological outcome of surviving children diagnosed with prenatally diagnosed ventriculomegaly is associated with the extent of VM before birth.Second objective: To determine whether theā¦
ID
Source
Brief title
Condition
- Neurological disorders congenital
- Structural brain disorders
- Foetal complications
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoints: The quality of GMs (in particular fidgety movements, FMs) at
13 weeks (range 11-15) after term from video recordings, using Prechtl*s method
of assessing General Movements, as Normal /Abnormal (Einspieler 1997), and
additionally the assessment of the Motor Optimality Score (MOS)(quantitative
score on details of the early motor repertoire, ranging from 5 (lowest
optimality) to 28 (highest optimality) (Bruggink 2009).
Secondary outcome
Secondary endpoint: Information about etiology and survival will be gathered
using a standard clinical form. Additionally, the quality of GMs will be
assessed one week after birth, at term age (+/- 2 weeks), and at 18 weeks (+/-
2 weeks) after term age using video recordings. The recordings will last 45
minutes if before term age, and 10 minutes from term age (38 weeks
postmenstrual age) onwards. Again, the GMs will be assessed as normal
/abnormal, and the Motor Optimality Score will be assessed. For recordings
before 42 weeks postmenstrual age we will use an age-adequate Motor Optimality
Score (MOS), ranging from 8 (least optimal) to 18 (most optimal) (De Vries
2008).
Background summary
Ventriculomegaly (VM) can be diagnosed from around 18-20 weeks of gestation. It
is one of the most common findings on prenatal ultrasound scan (Weichert 2010).
Since the introduction of the standardized ultrasound scan at 20 weeks of
gestation (SEO) in the Netherlands, the incidence of prenatally diagnosed VM
has increased (Robroch 2013). The screening with SEO is offered to all pregnant
women in the Netherlands.
The etiology of intrauterine VM is difficult to unravel when still in utero,
and thus neurodevelopmental outcome of these children is hard to predict. Some
studies have reported that mild and isolated VM are associated with more
favourable neurological outcome than more severe and progressive VM but others
could not confirm this finding. It is important to identify which prenatal
characteristics are the best indicators of outcome later in life, in order to
be able to counsel this increasing group of parents adequately. Whether the
etiology, extent of the VM and other characteristics such as progression of VM
or associated anomalies on ultrasound are predictors for survival and later
outcome is unknown, because until now studies have shown contradictive results
(Beeghly 2010, Weichert 2010).
By investigating the short-term neurological outcome of the surviving children
with VM it is possible to use a non-invasive method to identify children at
risk for neurological impairment. This is the qualitative assessment of General
Movements (GMs) from video recordings. This method has emerged as a reliable
and valid predictor of neurological outcome for the individual patient,
especially of motor deficits. GMs are present from fetal life onwards until 5
months after term and can reliably be assessed in early infancy. The method is
not only predictive of severe abnormalities later on, but also predictive of
mild motor abnormalities and cognitive delay (Bruggink 2008, Bruggink 2009,
Butcher 2009, Bruggink 2010).
In our study we aim to determine short term neurological outcome of children
with prenatally diagnosed VM in relation to the extent of VM, the associated
anomalies and the etiology of VM.
Study objective
Primary objective: To determine whether the short-term neurological outcome of
surviving children diagnosed with prenatally diagnosed ventriculomegaly is
associated with the extent of VM before birth.
Second objective: To determine whether the etiology of VM and presence of
associated anomalies is associated with short term neurological outcome of
children with prenatally diagnosed VM.
Study design
Prospective observational longitudinal cohort study.
Study burden and risks
Information gathering concerning etiology and outcome of the pregnancy is part
of standard care for pregnant women referred to the UMCG after SEO screening
(waiver Prenatal Diagnostics). The qualitative assessment of GMs from video
recordings is a sensitive, non-invasive, easy to apply method to assess brain
function, with good predictive value for neurological outcome. The non-invasive
character of video recording does not interfere with routine clinical care
since the camera will be placed in front of or next to the incubator or cot in
a way that caregivers are not hindered by the camera or lose sight on monitors.
Data from this study can not be obtained in another population, as we are
interested in early neonatal morbidity in this specific group of children. GMs
are age-sepcific and are only present from early fetal life onwards until the
end of the first half year of life.
The results of this study can help for a better understanding of the mechanisms
leading to neonatal morbidity and problems in neurological development in
children diagnosed with ventriculomegaly in the fetal period. This is very
valuable information because it will help professionals to inform and guide
parents in difficult decision-making when confronted with a pregnancy
complicated with fetal ventriculomegaly.
Hanzeplein 1
Groningen 9713GZ
NL
Hanzeplein 1
Groningen 9713GZ
NL
Listed location countries
Age
Inclusion criteria
Newborn child, aged < 1 week, having been diagnosed with ventriculomegaly (>10mm ventricular width) as fetus
Exclusion criteria
Diagnosis of spina bifida
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 | NL43522.042.13 |