Periventricular PseudocystsUDiPPPNCT05546801
Antenatal Ultrasound Diagnosis of Periventricular Pseudocysts and Postnatal Outcome
A study testing questionnaire in people with Periventricular Pseudocysts, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
The present study aims to improve the information given to the parents during the screening of periventricular pseudocysts in the Pluridisciplinary Center of Prenatal Diagnosis, with retrospective cases screened during the last 5 years in university hospital of Bordeaux. Read more about this study
- Who is it for?
- Ages 0 to 5 years
- Conditions the study is for
- Periventricular Pseudocysts
- What is being tested?
- questionnaire
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteFrance
- Study dates
- 12 Oct 2022to 1 Dec 2022
- Phase
- Interventional
- 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 0 to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Adult patient diagnosed with a periventricular cyst during a prenatal ultrasound at Bordeaux University Hospital between January 1, 2016 and December 31, 2020.
- Patient affiliated with or benefiting from a social security plan.
- Oral informed consent.
Who cannot join
- Subarachnoid cyst
- Blake's pouch cyst
- Choroid plexus cyst
- Periventricular leukomalacia
- Poor understanding of French
- Patient under legal protection.
Trial locations and contacts
1 site in 1 country.
About this study
The present study aims to improve the information given to the parents during the screening of periventricular pseudocysts in the Pluridisciplinary Center of Prenatal Diagnosis, with retrospective cases screened during the last 5 years in university hospital of Bordeaux.
Read the detailed description
Antenatal ultrasound screening for periventricular pseudocysts is steadily increasing, enabled in part by technological advances in ultrasound equipment.
Most of studies dealing with periventricular pseudocysts and subsequent neurodevelopment are based on neonatal screening, mostly performed in neonatal units.
Current data in the literature on the postnatal outcome of children screened antenatally are scarce; there are only 5 cohort studies with small numbers on the subject.
The present study aims to improve the information given to the parents during the screening of periventricular pseudocysts in the Pluridisciplinary Center of Prenatal Diagnosis, with retrospective cases screened during the last 5 years in university hospital of Bordeaux.
- Conditions
- Periventricular Pseudocysts
- Being tested
- questionnaire
- Keywords
- periventricular pseudocysts, postnatal development
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaireOther
questionnaire on postnatal development
| Study group | Role | What they receive |
|---|---|---|
| questionnaire | Experimental | Questionnaire on postnatal development Receives: Other: questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
postnatal child development
composite criterion as follows: Delayed acquisition is defined according to the standards of the Pediatric Society: age of sitting > 8 months, age of walking > 18 months, ability or not to associate 3 words at age 3. The use of a medical profession concerns follow-up by a speech therapist, a psychomotrician or a physiotherapist. It is not necessarily a periodic follow-up but a minimum of 2 consultations after the "assessment" consultation.
The scoring defines 2 groups,
- children with 0 points considered with a "normal" post-natal development
- children with 1 point or more considered with a post-natal development disorder.
Measured: Baseline
Secondary outcomes (2)
mother's medical history
mother's medical history
Measured: Baseline
medical history of the child
medical history of the child
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2022
- Study start12 Oct 2022
- Primary completion1 Dec 2022
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periventricular PseudocystsStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- questionnaire on postnatal development
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05546801
- Sponsor's protocol ID
- CHUBX 2022/14
- Other IDs
- 2022-A01504-39
- Acronym
- UDiPPP
- Status last verified
- Feb 2023
- First submitted
- 15 Sep 2022
- Last updated
- 29 May 2026
- 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 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antenatal Ultrasound Diagnosis of Periventricular Pseudocysts and Postnatal Outcome
- ClinicalTrials.gov ID
- NCT05546801
- Acronym / sponsor ID
- UDiPPP / CHUBX 2022/14
- Conditions
- Periventricular Pseudocysts
- Keywords
- periventricular pseudocysts, postnatal development
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 12 Oct 2022 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 21 Sep 2022 (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 present study aims to improve the information given to the parents during the screening of periventricular pseudocysts in the Pluridisciplinary Center of Prenatal Diagnosis, with retrospective cases screened during the last 5 years in university hospital of Bordeaux.
Detailed description
Antenatal ultrasound screening for periventricular pseudocysts is steadily increasing, enabled in part by technological advances in ultrasound equipment.
Most of studies dealing with periventricular pseudocysts and subsequent neurodevelopment are based on neonatal screening, mostly performed in neonatal units.
Current data in the literature on the postnatal outcome of children screened antenatally are scarce; there are only 5 cohort studies with small numbers on the subject.
The present study aims to improve the information given to the parents during the screening of periventricular pseudocysts in the Pluridisciplinary Center of Prenatal Diagnosis, with retrospective cases screened during the last 5 years in university hospital of Bordeaux.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- questionnaire on postnatal development
| Arm | Type | Receives |
|---|---|---|
| questionnaire | Experimental | Other: questionnaireQuestionnaire on postnatal development |
Who may qualify
- Ages
- 0 to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Adult patient diagnosed with a periventricular cyst during a prenatal ultrasound at Bordeaux University Hospital between January 1, 2016 and December 31, 2020.
- Patient affiliated with or benefiting from a social security plan.
- Oral informed consent.
Key exclusion criteria (6 listed)
- Subarachnoid cyst
- Blake's pouch cyst
- Choroid plexus cyst
- Periventricular leukomalacia
- Poor understanding of French
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 |
|---|---|---|
| questionnairequestionnaire on postnatal development | Other | questionnaire |
Primary outcome
postnatal child development
Time frame: Baseline
composite criterion as follows: Delayed acquisition is defined according to the standards of the Pediatric Society: age of sitting > 8 months, age of walking > 18 months, ability or not to associate 3 words at age 3. The use of a medical profession concerns follow-up by a speech therapist, a psychomotrician or a physiotherapist. It is not necessarily a periodic follow-up but a minimum of 2 consultations after the "assessment" consultation. The scoring defines 2 groups, * children with 0 points considered with a "normal" post-natal development * children with 1 point or more considered with a post-natal development disorder.
2 secondary outcomes
mother's medical history
Time frame: Baseline
medical history of the child
Time frame: Baseline
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 29 May 2026.
- 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?
A study testing questionnaire in people with Periventricular Pseudocysts, run by University Hospital, Bordeaux 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 29 May 2026. 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?
postnatal child development (time frame: Baseline). 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 29 May 2026.