First Observatory of Precocious and Advanced Puberty in Private Healthcare.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 3,360
- 试验地点
- 23
- 主要终点
- Number of recruited patients with at least 80% of the main data collected
研究概览
简要总结
The age of puberty has fluctuated throughout history. Recent data shows an increase in the age of onset of puberty signs, in the United States but also in Europe. A recent Public Health France study published in 2018 reports an increase in the incidence of precocious puberty with geographical heterogeneity. The consequences of these appearances include the early onset of menarche, short adult height and the psychological impact.
Due to a lack of studies and additional data, the reasons for this development are difficult to understand. Among current hypotheses, the entanglement with the evolution of our environment is at the forefront: the action of environmental endocrine disruptors and nutritional factors could play a role in the process of early appearance of pubertal signs.
The establishment of a national observatory for early and advanced puberty in collaboration with pediatric endocrinologists (on the front line) would allow a reliable and precise field approach, capable of supplementing epidemiological data, which are currently insufficient.
The investigators hypothesize that the establishment of an observatory of pubertal advances (early puberty and advanced puberty) in private medicine is possible, with inclusion of at least 75% of eligible patients, and collection of at least 80% of data.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Precocious puberty group (PP) :
- •Suspected precocious puberty (girl aged < 8 years or boy aged < 9 years when the first signs of development* appear)
- •Suspected precocious puberty (girl aged < 8 years or boy aged < 9 years when the first signs of development* appear)
- •Advanced puberty group (AP) :
- •Suspected advanced puberty (girl aged ≥ 8 and < 10 years or boy aged ≥ 9 and < 11 years when the first signs of development* appear)
- •First consultation with the investigator (pediatric endocrinologist).
- •Control group :
- •Boy or girl without signs of pubertal development (Tanner 1);
- •Matched to the PP group on sex and age (+/- 1 year);
- •Consultation with the same investigator over the same period (same quarter) as a patient in the PP group
排除标准
- •Consultation with the same investigator over the same period (same quarter) as a patient in the PP group
- •Family not speaking French, language barrier.
研究组 & 干预措施
Precocious puberty group
Girl < 8 years old or boy < 9 years old when the first signs of development appear.
Advanced puberty group
Girl aged ≥ 8 and < 10 years or boy ≥ 9 and < 11 years old when the first signs of development appear.
Control group
Boy or girl without any signs of puberty development (Tanner 1)
结局指标
主要结局
Number of recruited patients with at least 80% of the main data collected
时间窗: Up to 48 month
Number of recruited patients with at least 80% of the main data collected (weight, height, BMI, pubertal stage, date of onset of pubertal signs, questionnaires).
Missing data rate
时间窗: Up to 48 month
Missing data rate less than 10% for pubertal stage.
At least 75% of patients included
时间窗: Up to 48 month
At least 75% of patients included compared to the number of eligible patients.
次要结局
未报告次要终点