Long-term Outcome of Newborns With an Isolated Small Cerebellum

Cerebellar Hypoplasia Clinical Trial

— PECERI  

Official title:

Perinatal and Long-term Outcome of Newborns With an Isolated Small Transverse Cerebellar Diameter

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03572868
• Other study ID #: 69HCL18_0273
• Status: Completed
• Start date: October 9, 2018
• Est. completion date: October 10, 2018

Study information

• Verified date: March 2019
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: October 10, 2018
• Est. primary completion date: October 10, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Cerebellar Hypoplasia

Intervention

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.

Locations

Country	Name	City	State
France	Service Obstétrique - Hôpital Femme Mère Enfant - Groupement Hospitalier Est	Bron

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Development Quotient.	Development Quotient of each child established from CDI questionnaire (Child Development Inventory).	between 3 and 10 years after birth