Cerebellar HypoplasiaPECERINCT03572868
Long-term Outcome of Newborns With an Isolated Small Cerebellum
An observational study of Cerebellar Hypoplasia, run by Hospices Civils de Lyon at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebellar Hypoplasia
- What is being tested?
- Evaluation of the long term neurodevelopmental outcome
- How many people
- 37 participants
- Where
- 1 siteFrance
- Study dates
- 9 Oct 2018to 10 Oct 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Service Obstétrique - Hôpital Femme Mère Enfant - Groupement Hospitalier Est
Bron, 69677
About this study
Official title: 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.
- Conditions
- Cerebellar Hypoplasia
- Being tested
- Evaluation of the long term neurodevelopmental outcome
- Medical subject headings
- Cerebellar Hypoplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of the long term neurodevelopmental outcomeOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Development Quotient.
Development Quotient of each child established from CDI questionnaire (Child Development Inventory).
Measured: between 3 and 10 years after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2018
- Study start9 Oct 2018
- Primary completion10 Oct 2018
- Study completion10 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebellar HypoplasiaStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03572868
- Sponsor's protocol ID
- 69HCL18_0273
- Acronym
- PECERI
- Status last verified
- Mar 2019
- First submitted
- 19 Jun 2018
- Last updated
- 20 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perinatal and Long-term Outcome of Newborns With an Isolated Small Transverse Cerebellar Diameter
- ClinicalTrials.gov ID
- NCT03572868
- Acronym / sponsor ID
- PECERI / 69HCL18_0273
- Conditions
- Cerebellar Hypoplasia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 9 Oct 2018 (actual)
- Primary completion
- 10 Oct 2018 (actual)
- Study completion
- 10 Oct 2018 (actual)
- First posted
- 28 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Evaluation of the long term neurodevelopmental outcomeEvaluation 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. | Other | – |
Primary outcome
Development Quotient.
Time frame: between 3 and 10 years after birth
Development Quotient of each child established from CDI questionnaire (Child Development Inventory).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2019.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebellar Hypoplasia, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development Quotient. (time frame: between 3 and 10 years after birth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2019.