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临床试验/CTRI/2023/03/050455
CTRI/2023/03/050455尚未招募不适用

Determining the prevalence and risk factors associated with precocious puberty among pre-pubertal girls in Mumbai

ICMR-National Institute for research in reproductive and Child Health1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2023年3月13日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
500
试验地点
1
主要终点
1.Magnitude and risk factors associated early Puberty in community

研究概览

简要总结

Background

Precocious puberty (PP) is defined as the appearance of secondary sex characteristics before age 8 years in girls. It may manifest with either development of all the secondary sexual features (progressive PP) or as isolated premature thelarche, adrenarche or menarche. Environmental variables, weight, foetal nutrition, childhood dietary habits, physical activity, psychological factors, genetic factors and/or endocrine disrupting chemicals are known to affect timing of puberty.

There has been ethnic and geographical variation in timing of puberty globally. It is seen that very few prospective studies have been undertaken globally to understand prevalence of PP and majority studies have focussed only retrospective assessment on basis of early menarche. There is lack of information on prevalence, associated factors, EDCs as risk factors of early puberty from India.  Recent increase in incidence of childhood obesity and precocity during pandemic times has been reported in Indian newspapers. Hence, there is an urgent need of evidence on magnitude and risk factors associated with precocious puberty in Indian setting. Therefore, the present study is planned to determine the prevalence and risk factors associated with Precocious puberty among   pre-pubertal girls in Mumbai

Novelty

There has been ethnic and geographical variation in timing of puberty globally. However, majority studies have focussed only retrospective assessment of precocious puberty on basis of early menarche, especially with respect to studies in India. Majority studies have focussed on visual grading of breast stages. There is limited information on pubertal staging to document a trend to earlier maturation. Also, there is lack of information on prevalence, associated factors and determinants of early puberty from India  It is crucial to    puberty timely to initiate treatment as intervention is  not possible at later stage.

There is an urgent need of evidence on magnitude and risk factors associated with precocious puberty in Indian setting

Objectives

Primary Objective

To determine the prevalence of precocious puberty (Premature thelarche, adrenarche and menarche) among girls in the age group of 6-9 years

Secondary Objective

1.   To evaluate the risk factors associated with precocious puberty among girls in the age group of 6-9 years

2. To assess the knowledge about pubertal changes, health seeking behavior and attitude towards imparting pubertal information to girls among mothers

3.   To evaluate association of precocious puberty and exposure of endocrine disrupting chemicals

 Methods

A prospective study will be carried out at community Clinic over a period of 2 years. Approximately 1000 girls in the age group of 6 -9 years from the schools in the vicinity with will be included.

Girls with diagnosis of early puberty will undergo detail History and Baseline hormonal investigations, USG, Bone age will also be recorded.  Baseline values of Kisspeptin, Neurokinin B, Neuropeptide Y and MKRN3 protein will be estimated. The levels will be repeated at the end of treatment to evaluate therapeutic relevance.

Expected Outcome

The study will help us to understand the determinants of ICPP and incomplete puberty and explore Clinical and therapeutic relevance.

研究设计

研究类型
Observational

入排标准

年龄范围
6.00 Year(s) 至 9.00 Year(s)(—)
性别
Female

入选标准

  • Girls in the age group of 6-9 years in municipal and private schools in community Precocious puberty case definition: Girls presenting with one of the following which has onset <8 YEARS: TANNER STAGE 2 BREAST BUDDING AND/OR PUBIC HAIR GROWTH AND/OR AXILLARY HAIR AND/OR MENARCHE.

排除标准

  • Girls of parents who are not willing to give consent.

结局指标

主要结局

1.Magnitude and risk factors associated early Puberty in community

时间窗: Preparatory phase- 3 months | Data Collection phase-15 months | Data anlysis-3 months

3.Acceptability and Perceptions of parents towards diagnosis and treatment –Generate awareness among gatekeepers

时间窗: Preparatory phase- 3 months | Data Collection phase-15 months | Data anlysis-3 months

2.Diagnose precautious puberty and intervene early

时间窗: Preparatory phase- 3 months | Data Collection phase-15 months | Data anlysis-3 months

次要结局

  • Magnitude and risk factors associated early Puberty in community(Preparatory phase- 3 months)

研究者

发起方
ICMR-National Institute for research in reproductive and Child Health
申办方类型
Research institution

研究点 (1)

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