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Long-term Outcome of Newborns With an Isolated Small Cerebellum

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03572868
Acronym
PECERI
Enrollment
37
Registered
2018-06-28
Start date
2018-10-09
Completion date
2018-10-10
Last updated
2019-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebellar Hypoplasia

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.

Interventions

OTHEREvaluation 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.

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Development Quotient.between 3 and 10 years after birthDevelopment Quotient of each child established from CDI questionnaire (Child Development Inventory).

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026