- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05546801
Antenatal Ultrasound Diagnosis of Periventricular Pseudocysts and Postnatal Outcome (UDiPPP)
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Bordeaux, France
- CHU Bordeaux
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Subarachnoid cyst
- Blake's pouch cyst
- Choroid plexus cyst
- Periventricular leukomalacia
- Poor understanding of French
- Patient under legal protection.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: questionnaire
Questionnaire on postnatal development
|
questionnaire on postnatal development
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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,
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
mother's medical history
Time Frame: Baseline
|
mother's medical history
|
Baseline
|
|
medical history of the child
Time Frame: Baseline
|
medical history of the child
|
Baseline
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHUBX 2022/14
- 2022-A01504-39 (Other Identifier: ANSM)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Periventricular Pseudocysts
-
University of FloridaCompletedPancreatic PseudocystsUnited States
-
Shyam VaradarajuluCompletedPancreatic PseudocystsUnited States
-
Children's Hospital of PhiladelphiaCompletedCardiac Surgery | Congenital Heart Disease | Fetal Neuroprotection | Periventricular Leucomalacia | Brain Development | Neurodevelopmental DisabilityUnited States
-
Hong HuangEunice Kennedy Shriver National Institute of Child Health and Human Development...CompletedBrain Injury | Intraventricular Hemorrhage | Periventricular Leukomalacia | Renal InjuryUnited States
-
University of MinnesotaEunice Kennedy Shriver National Institute of Child Health and Human Development...CompletedCerebral Palsy | Perinatal Stroke | Periventricular LeukomalaciaUnited States
-
Rohto Pharmaceutical Co., Ltd.CompletedCerebral Palsy | Periventricular LeukomalaciaJapan
-
IRCCS Fondazione Stella MarisUniversity of Pisa; University of MilanCompletedPeriventricular LeukomalaciaItaly
-
Universitair Ziekenhuis BrusselCompletedIntraventricular Hemorrhage | Prematurity; Extreme | Periventricular Leukomalacia | Cerebral Circulatory FailureBelgium
-
University of AlbertaCanadian Institutes of Health Research (CIHR)Active, not recruitingSpastic Diplegia | Periventricular LeukomalaciaCanada
-
University Hospital, RouenMinistry of Health, FranceCompletedBrain Ischemia | Preterm Birth | Intracranial Hemorrhages | Periventricular LeukomalaciaFrance
Clinical Trials on questionnaire
-
H. Lee Moffitt Cancer Center and Research InstituteSan Diego State University; University of Minnesota; University of ArizonaCompletedAnxiety | Psychological StressUnited States
-
Centre Hospitalier Universitaire de NiceCompletedGeneral Population | TDAH | Children Aged 5 to 18 YearsFrance
-
Stanford UniversityRecruitingAstigmatism | Nearsightedness | FarsightednessUnited States
-
University Medical Center GoettingenCompletedOrofacial Pain | Sleep ProblemsGermany
-
University of LiegeCompletedCritical Illness | Covid19 | Psychological Stress | FamilyBelgium
-
Imperial College Healthcare NHS TrustNot yet recruitingCervical Myelopathy
-
Children's Hospitals and Clinics of MinnesotaCompletedFirearm Injury | Firearm Safety | Firearm OwnershipUnited States
-
Fondazione Policlinico Universitario Agostino Gemelli...Recruiting
-
Imperial College LondonRoyal Marsden NHS Foundation Trust; University College London Hospitals; The... and other collaboratorsCompleted
-
University Hospital, Clermont-FerrandCompletedQuality of Life | Dentin HypersensitivityFrance