Long-term Outcome of Newborns With an Isolated Small Cerebellum

Overview

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.

Full Title of Study: “Perinatal and Long-term Outcome of Newborns With an Isolated Small Transverse Cerebellar Diameter”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: October 10, 2018

Interventions

  • 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.

Clinical Trial Outcome Measures

Primary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Hospices Civils de Lyon
  • Provider of Information About this Clinical Study
    • Sponsor

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.