Long-term Outcome of Newborns With an Isolated Small Cerebellum (PECERI)
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|ClinicalTrials.gov Identifier: NCT03572868|
Recruitment Status : Completed
First Posted : June 28, 2018
Last Update Posted : March 20, 2019
The decreased cerebellar biometry during second and third trimester ultrasound examination is the main parameter to diagnoses cerebellar and pontocerebellar hypoplasia. Investigators already described that a transverse cerebellar diameter (TCD) below the 5th centile at second or third trimester scan is related to a high rate of fetal malformations, severe intrauterine restriction in growth, chromosomal anomalies and genetic disorders, therefore when facing a TCD below the 5th centile, patients should be referred for oriented sonogram, fetal MRI (Magnetic resonance imaging) and fetal karyotyping.
However, prenatal counseling in case of an isolated decreased cerebellar biometry remains challenging since there are no data in the literature regarding the neurodevelopmental outcome of these newborns. The aim of this work is to evaluate the neurodevelopmental outcome of newborns with a prenatal isolated decreased cerebellar biometry, in order to improve prenatal counseling.
|Condition or disease||Intervention/treatment|
|Cerebellar Hypoplasia||Other: Evaluation of the long term neurodevelopmental outcome|
|Study Type :||Observational|
|Actual Enrollment :||37 participants|
|Official Title:||Perinatal and Long-term Outcome of Newborns With an Isolated Small Transverse Cerebellar Diameter|
|Actual Study Start Date :||October 9, 2018|
|Actual Primary Completion Date :||October 10, 2018|
|Actual Study Completion Date :||October 10, 2018|
- Other: Evaluation of the long term neurodevelopmental outcome
Evaluation of the long-term neurodevelopmental outcome of newborns who have an isolated transverse cerebellar diameter < 5th centile during the second or the third trimester of pregnancy.
- Development Quotient. [ Time Frame: between 3 and 10 years after birth ]Development Quotient of each child established from CDI questionnaire (Child Development Inventory).
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03572868
|Service Obstétrique - Hôpital Femme Mère Enfant - Groupement Hospitalier Est|
|Bron, France, 69677|