NCT05546801

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 15, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 21, 2022

Completed
21 days until next milestone

Study Start

First participant enrolled

October 12, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

May 29, 2026

Status Verified

February 1, 2023

Enrollment Period

2 months

First QC Date

September 15, 2022

Last Update Submit

May 28, 2026

Conditions

Keywords

periventricular pseudocystspostnatal development

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline

Secondary Outcomes (2)

  • mother's medical history

    Baseline

  • medical history of the child

    Baseline

Study Arms (1)

questionnaire

EXPERIMENTAL

Questionnaire on postnatal development

Other: questionnaire

Interventions

questionnaire on postnatal development

questionnaire

Eligibility Criteria

Age0 Years - 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • Subarachnoid cyst
  • Blake's pouch cyst
  • Choroid plexus cyst
  • Periventricular leukomalacia
  • Poor understanding of French
  • Patient under legal protection.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Bordeaux

Bordeaux, France

Location

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: questionnaire on postnatal development
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 15, 2022

First Posted

September 21, 2022

Study Start

October 12, 2022

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

May 29, 2026

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations