Psychosocial Impact of Early Puberty in Girls Aged 6 to 8 Years
NCT ID: NCT01679925
Last Updated: 2015-03-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
30 participants
OBSERVATIONAL
2012-10-31
2015-02-28
Brief Summary
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The overall objective of this work is to improve the conditions leading to the therapeutic decision and the procedures for monitoring girls with idiopathic central precocious puberty.
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Detailed Description
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* A clinical examination with pubertal stage assessment.
* A GnRH test
* A Pelvic ultrasound
* An MRI will be performed later after the results of GnRH test confirming precocious central puberty.
These reviews are conducted as part of usual care and are required to validate the inclusion criteria of patients.
The CBCL questionnaire will be completed by patient's parents and the first semi-structured interview will be conducted by a sociologist assisted by the psychologist, dedicated to the study.
Patient's follow-up will be planned 6 months after inclusion, including similar investigations (except MRI).
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Onset of clinical signs between 6 and 8 years excluded: breast development (Tanner stage S2 or more), possibly with pubic hair or accelerated growth rate.
* The GnRH test: LH peak\> 5 IU / l during the test.
* Pelvic ultrasound: uterine length\> 34 mm
* The normality of the hypothalamic-pituitary region assessed by magnetic resonance imaging (MRI).
* Parental Informed and written consent
Exclusion Criteria
* Other chronic disease
* The child does not benefit of the French social security cover
6 Years
8 Years
FEMALE
No
Sponsors
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Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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Dominique SIMON, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Locations
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Assistance Publique - Hôpitaux de Paris
Paris, Paris, France
Countries
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Other Identifiers
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P111010
Identifier Type: -
Identifier Source: org_study_id
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