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CompletedNCT03572868PECERIUpdated Mar 20, 2019

Long-term Outcome of Newborns With an Isolated Small Cerebellum

An observational study in Cerebellar Hypoplasia, sponsored by Hospices Civils de Lyon. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-03-20.

Sponsored by Hospices Civils de Lyon · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
37
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Cerebellar Hypoplasia
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In context

Lead sponsor

Hospices Civils de Lyon is the lead sponsor of 1,826 studies on the registry; 439 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

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

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

Observational model
Cohort
Time perspective
Prospective
Enrollment
37 participants (actual)
Patient registry
No

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.

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What researchers measure

Primary outcomes

  1. Development Quotient.

    Development Quotient of each child established from CDI questionnaire (Child Development Inventory).

    Time frame: between 3 and 10 years after birth

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Study locations

1 site
  • Service Obstétrique - Hôpital Femme Mère Enfant - Groupement Hospitalier Est
    Bron, 69677, France
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 20, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03572868
Lead sponsor
Hospices Civils de Lyon
Responsible party
Sponsor
First posted
Jun 28, 2018
Start date
Oct 9, 2018
Primary completion
Oct 10, 2018
Completion
Oct 10, 2018
Last update
Mar 20, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.

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