PUPSYAssessment of Psychosocial Impact in Girls with Early Puberty Aged 6 to 8 Years
This study aims to observe and understand the psychosocial characteristics and concerns of girls aged 6 to 8 years who are experiencing early puberty, as well as their families' perceptions and expectations regarding hormone therapy.
Data Collection
Collected from today forward - ProspectiveEndocrine System Diseases
+ Gonadal Disorders
+ Puberty, Precocious
Cohort
Tracking disease incidence in order to identify risk factors and understand disease progression over time.Summary
Study start date: October 1, 2012
Actual date on which the first participant was enrolled.During the day hospital, the diagnostic workup for precocious puberty will be performed and include: 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).
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.30 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Cohort
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.From 6 to 8 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: 6 to 8 years old girls, with idiopathic central precocious puberty defined as: 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: Parents and / or children do not speak French Other chronic disease The child does not benefit of the French social security cover
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Assistance Publique - Hôpitaux de Paris
Paris, FranceOpen Assistance Publique - Hôpitaux de Paris in Google Maps