Long-term Outcome of Newborns With an Isolated Small Cerebellum

Completed

• Conditions: Cerebellar Hypoplasia

• Registration Number: NCT03572868
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-06-19
• Study First Submitted QC: 2018-06-19
• Study First Posted: 2018-06-28
• Study Start: 2018-10-09
• Primary Completion: 2018-10-10
• Study Completion: 2018-10-10
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-18
• Last Update Posted: 2019-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

Inclusion Criteria

• 2nd or the 3rd trimester ultrasound examination realized at the hospital "Femme Mère Enfant" in Lyon between 2008 and 2015
• Isolated Transverse cerebellar diameter <5th centile
• Parents who received the information and did not object to participate to the study

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Exclusion Criteria

• Decreased Transverse cerebellar diameter with associated malformations diagnosed during prenatal period
• Family history of neurodevelopmental delay or cognitive impairment
• Preterm delivery (< 28 WG)
• Severe restriction in growth at birth (<3e centile)
• Neonatal asphyxia (pH blood cord < 7)
• Apgar score < 7 at 5 min of live with transfer to the neonatal intensive care unit

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Development Quotient.	between 3 and 10 years after birth	Development Quotient of each child established from CDI questionnaire (Child Development Inventory).

Trial Locations

Locations (1)

Service Obstétrique - Hôpital Femme Mère Enfant - Groupement Hospitalier Est; 🇫🇷 Bron, France