Fetal Neurodevelopmental DisorderNCT06782802
Clinical Significance and Prognostic Value of Prenatal Diagnosis of Obliteration of the Cavum Septum Pellucidum
An observational study of Fetal Neurodevelopmental Disorder and Cavum Septum Pellucidum, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial summary
The aim of this observational study is to evaluate the incidence of the occurrence of additional abnormalities in fetuses diagnosed with cavum septum pellucidum (CSP) obliteration performed at second-trimester ultrasound, as well as to analyze the postnatal neurological outcome. Read more about this study
- Who is it for?
- Ages 28 days to 44 years, women only
- Conditions the study is for
- Fetal Neurodevelopmental Disorder, Cavum Septum Pellucidum
- How many people
- 15 participants
- Where
- 1 siteItaly
- Study dates
- 7 Mar 2022to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 28 days to 44 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: Participants followed at our center between 01/01/2014 and 31/05/2021 with a morphologic ultrasound showing an obliteration of the cavum septum pellucidum will be recruited.
Who may be able to join
- Pregnant participants with a diagnosis of cavum septum pellucidum obliteration made at second-trimester morphologic ultrasound between 19+0 and 21+6 weeks
- Age > or = 18 years at the time of outpatient access
- Acquisition of informed consent form, from the patient and minor
- Patients followed at our center
Who cannot join
- None
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, Bologna, 40138
Gianluigi Pilu, MD, 0512143493, gianluigi.pilu@aosp.bo.it
About this study
The aim of this observational study is to evaluate the incidence of the occurrence of additional abnormalities in fetuses diagnosed with cavum septum pellucidum (CSP) obliteration performed at second-trimester ultrasound, as well as to analyze the postnatal neurological outcome.
Read the detailed description
In cases of failure to visualize the CSP (obliterated or absent) and additional brain anatomical abnormalities, the feto-neonatal prognosis turns out to be mainly related to the type of associated malformation. It is still debated, however, the prognosis of an absent or isolated obliteration of the SPC in the presence of remaining regular brain anatomy for the time.
Very often, the patient is offered fetal brain MRI, which, compared with ultrasonography, appears to be endowed with greater accuracy in identifying any additional associated cerebral animals. In our center, it is a shared custom to routinely offer the patient the option of performing an MRI, in all cases of failure to visualize the SPC.
If obliteration of the CSP is confirmed as isolated, normal clinical practice is to perform monthly ultrasound monitoring and a second MRI at approximately 30 to 32 weeks, with the aim of ruling out the appearance of further developmental abnormalities. In addition, a specialized pediatric evaluation is usually performed after birth with the aim of following the child developmentally.
In a retrospective manner, clinical data of patients followed at our center from 01/01/2024 to 31/05/2021, with a finding of obliteration of the CSP at the second trimester, will be considered. Of these patients, data from the morphologic ultrasound and concomitant neurosonography and subsequent MRI (if performed) will be analyzed, as well as those that emerged during follow-ups performed until the end of pregnancy. For the purpose of assessing the fetal neurological outcome, such patients will be contacted by telephone, the study will be explained to them, and a proposal will be made for a psychiatric examination at the department of child neuropsychiatry for their child. During this visit the child will be administered psycho-aptitude tests routinely used, according to normal clinical practice, in neurodevelopmental assessment, in accordance with the child's age.
If the patients do not agree to have their children undergo this visit, only the analysis of the data collected during the visits, performed during pregnancy, will be done.
- Keywords
- Cavum septum pellucidum
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the incidence of brain abnormalities
Evaluation of the incidence of associated brain abnormalities, diagnosed by neurosonography and MRI, both at the time of diagnosis and found at subsequent planned follow-ups until the end of pregnancy in fetuses with a finding of obliteration of the cavum septum pellucidum
Measured: During second-trimester ultrasound
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2025
- Study start7 Mar 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fetal Neurodevelopmental DisorderStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe 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
- Retrospective
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gianluigi Pilu, MD, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06782802
- Sponsor's protocol ID
- CSP21
- Status last verified
- Oct 2024
- First submitted
- 3 Dec 2024
- Last updated
- 20 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Significance and Prognostic Value of Prenatal Diagnosis of Obliteration of the Cavum Septum Pellucidum
- ClinicalTrials.gov ID
- NCT06782802
- Acronym / sponsor ID
- CSP21
- Keywords
- Cavum septum pellucidum
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 7 Mar 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 20 Jan 2025 (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 aim of this observational study is to evaluate the incidence of the occurrence of additional abnormalities in fetuses diagnosed with cavum septum pellucidum (CSP) obliteration performed at second-trimester ultrasound, as well as to analyze the postnatal neurological outcome.
Detailed description
In cases of failure to visualize the CSP (obliterated or absent) and additional brain anatomical abnormalities, the feto-neonatal prognosis turns out to be mainly related to the type of associated malformation. It is still debated, however, the prognosis of an absent or isolated obliteration of the SPC in the presence of remaining regular brain anatomy for the time.
Very often, the patient is offered fetal brain MRI, which, compared with ultrasonography, appears to be endowed with greater accuracy in identifying any additional associated cerebral animals. In our center, it is a shared custom to routinely offer the patient the option of performing an MRI, in all cases of failure to visualize the SPC.
If obliteration of the CSP is confirmed as isolated, normal clinical practice is to perform monthly ultrasound monitoring and a second MRI at approximately 30 to 32 weeks, with the aim of ruling out the appearance of further developmental abnormalities. In addition, a specialized pediatric evaluation is usually performed after birth with the aim of following the child developmentally.
In a retrospective manner, clinical data of patients followed at our center from 01/01/2024 to 31/05/2021, with a finding of obliteration of the CSP at the second trimester, will be considered. Of these patients, data from the morphologic ultrasound and concomitant neurosonography and subsequent MRI (if performed) will be analyzed, as well as those that emerged during follow-ups performed until the end of pregnancy. For the purpose of assessing the fetal neurological outcome, such patients will be contacted by telephone, the study will be explained to them, and a proposal will be made for a psychiatric examination at the department of child neuropsychiatry for their child. During this visit the child will be administered psycho-aptitude tests routinely used, according to normal clinical practice, in neurodevelopmental assessment, in accordance with the child's age.
If the patients do not agree to have their children undergo this visit, only the analysis of the data collected during the visits, performed during pregnancy, will be done.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 28 days to 44 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Participants followed at our center between 01/01/2014 and 31/05/2021 with a morphologic ultrasound showing an obliteration of the cavum septum pellucidum will be recruited.
Key inclusion criteria (4 listed)
- Pregnant participants with a diagnosis of cavum septum pellucidum obliteration made at second-trimester morphologic ultrasound between 19+0 and 21+6 weeks
- Age > or = 18 years at the time of outpatient access
- Acquisition of informed consent form, from the patient and minor
- Patients followed at our center
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Assessment of the incidence of brain abnormalities
Time frame: During second-trimester ultrasound
Evaluation of the incidence of associated brain abnormalities, diagnosed by neurosonography and MRI, both at the time of diagnosis and found at subsequent planned follow-ups until the end of pregnancy in fetuses with a finding of obliteration of the cavum septum pellucidum
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2025.
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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.
Gianluigi Pilu, MD principal investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
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 Fetal Neurodevelopmental Disorder and Cavum Septum Pellucidum, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
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 4 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 20 Jan 2025. 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 Italy. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gianluigi Pilu, MD (0512143493, gianluigi.pilu@aosp.bo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the incidence of brain abnormalities (time frame: During second-trimester ultrasound). 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 Jan 2025.