Long-term Outcome of Newborns With an Isolated Small Cerebellum (PECERI)

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

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.

Study Overview

• Status: Completed
• Conditions: Cerebellar Hypoplasia
• Intervention / Treatment: Other: Evaluation of the long term neurodevelopmental outcome

• Study Type: Observational
• Enrollment (Actual): 37

Contacts and Locations

Study Locations

• France
  • Bron, France, 69677
    • Service Obstétrique - Hôpital Femme Mère Enfant - Groupement Hospitalier Est

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Parents of newborns who have an isolated transverse cerebellar diameter < 5th centile during the 2nd or the 3rd trimester ultrasound examination realized at the hospital Femme Mère Enfant in Lyon between 2008 and 2015.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Development Quotient.	Development Quotient of each child established from CDI questionnaire (Child Development Inventory).	between 3 and 10 years after birth

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): October 9, 2018
• Primary Completion (Actual): October 10, 2018
• Study Completion (Actual): October 10, 2018

Study Registration Dates

• First Submitted: June 19, 2018
• First Submitted That Met QC Criteria: June 19, 2018
• First Posted (Actual): June 28, 2018

Study Record Updates

• Last Update Posted (Actual): March 20, 2019
• Last Update Submitted That Met QC Criteria: March 18, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 69HCL18_0273

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No