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

Completed

• Conditions: 10029299; enlarged brain ventricles; Ventriculomegaly; 10042258; 10016849

• Registration Number: NL-OMON38456
• Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 24

Inclusion Criteria

Newborn child, aged < 1 week, having been diagnosed with ventriculomegaly (>10mm ventricular width) as fetus

Exclusion Criteria

Diagnosis of spina bifida

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoints: The quality of GMs (in particular fidgety movements, FMs) at<br /><br>13 weeks (range 11-15) after term from video recordings, using Prechtl*s method<br /><br>of assessing General Movements, as Normal /Abnormal (Einspieler 1997), and<br /><br>additionally the assessment of the Motor Optimality Score (MOS)(quantitative<br /><br>score on details of the early motor repertoire, ranging from 5 (lowest<br /><br>optimality) to 28 (highest optimality) (Bruggink 2009). </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoint: Information about etiology and survival will be gathered<br /><br>using a standard clinical form. Additionally, the quality of GMs will be<br /><br>assessed one week after birth, at term age (+/- 2 weeks), and at 18 weeks (+/-<br /><br>2 weeks) after term age using video recordings. The recordings will last 45<br /><br>minutes if before term age, and 10 minutes from term age (38 weeks<br /><br>postmenstrual age) onwards. Again, the GMs will be assessed as normal<br /><br>/abnormal, and the Motor Optimality Score will be assessed. For recordings<br /><br>before 42 weeks postmenstrual age we will use an age-adequate Motor Optimality<br /><br>Score (MOS), ranging from 8 (least optimal) to 18 (most optimal) (De Vries<br /><br>2008).</p><br>