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Early neurological outcome of prenatally diagnosed ventriculomegaly at 20 weeks of gestation standardized ultrasound scan

Early neurological outcome of prenatally diagnosed ventriculomegaly at 20 weeks of gestation standardized ultrasound scan - Early neurological outcome of prenatally diagnosed ventriculomegaly

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON38456
Enrollment
24
Registered
2013-09-24
Start date
2013-06-01
Completion date
Unknown
Last updated
2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

enlarged brain ventricles Ventriculomegaly

Interventions

None listed

Sponsors

Universitair Medisch Centrum Groningen
Lead Sponsor

Eligibility

Age
2 Years to 11 Years

Inclusion criteria

Inclusion criteria: Newborn child, aged 10mm ventricular width) as fetus

Exclusion criteria

Exclusion criteria: Diagnosis of spina bifida

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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).

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)