Normative Brain Volume Profiles From Multicenter Fetal MRI

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age20-37
SponsorAssistance Publique Hopitaux De Marseille

About this trial

Fetal brain MRI is an essential diagnostic tool to inform parents about the prognosis of abnormalities detected on routine ultrasound. Recent work has shown that brain MRI measurements at the antenatal stage are predictive of the child's postnatal development. However, this work remains limited to basic research, in part because of the lack of normative curves of brain tissue volume evolution from fetal MRI acquired in clinical routine. This project aims to fill this gap. For this purpose, the project will exploit fetal MRI scans acquired in 4 French hospitals (Marseille, Nice, Montpellier and Paris): MRI scans without abnormalities will be centralized for analysis, and families who have undergone these scans will be contacted to evaluate the development of their children after birth. Normative curves will be established by applying a set of treatments developed by the laboratory in Marseille collaborating in the project. Ultimately, these curves will help to clarify the diagnosis of fetuses by providing a quantitative characterization of the normality of brain measurements.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

Child suffering from a commissural malformation (anomaly of the corpus callosum)

Child with a genetic syndrome and/or chromosomal abnormality and/or deleterious mutation

Child with syndromic extra-cerebral malformations (including cardiac malformations)

Child with intrauterine growth restriction reported in the obstetrical record

Trial population

Homogeneous group of fetuses who received an MRI more than 3 years ago, with normal MRI and normal neurological development at 3 years (see inclusion criteria). Included individuals (at the fetal stage) will be evaluated at 3+ years post-birth.

Trial design

Design model

Other

Time perspective

Retrospective

Treatments tested in this trial

  • Questionnaire

    Other intervention

    Questionnaire about children development

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Determine normative brain volume curves

Curves calculated from fetal brain MRIs in fetuses between 20 and 37 weeks of amenorrhea with normal postnatal neurological development

Time frame
Through study completion, an average of 3 year

Secondary outcomes

1

Statistically compare the normative curves obtained with standard articles in the literature.

Comparaison of Size effect, confidence intervals obtained with those reported in the reference articles

Time frame
Through study completion, an average of 3 year
2

Sensitivity study: Possible influence of the scanner type on the estimated normative curves.

MRI scanner model

Time frame
Through study completion, an average of 3 year

Other outcomes

Sponsors and contacts

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