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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03572868
Recruitment Status : Completed
First Posted : June 28, 2018
Last Update Posted : March 20, 2019
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

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.


Condition or disease Intervention/treatment
Cerebellar Hypoplasia Other: Evaluation of the long term neurodevelopmental outcome

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Study Type : Observational
Actual Enrollment : 37 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Perinatal and Long-term Outcome of Newborns With an Isolated Small Transverse Cerebellar Diameter
Actual Study Start Date : October 9, 2018
Actual Primary Completion Date : October 10, 2018
Actual Study Completion Date : October 10, 2018

Resource links provided by the National Library of Medicine



Intervention Details:
  • 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.


Primary Outcome Measures :
  1. Development Quotient. [ Time Frame: between 3 and 10 years after birth ]
    Development Quotient of each child established from CDI questionnaire (Child Development Inventory).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03572868


Locations
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France
Service Obstétrique - Hôpital Femme Mère Enfant - Groupement Hospitalier Est
Bron, France, 69677
Sponsors and Collaborators
Hospices Civils de Lyon

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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03572868     History of Changes
Other Study ID Numbers: 69HCL18_0273
First Posted: June 28, 2018    Key Record Dates
Last Update Posted: March 20, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No