NL-OMON48505尚未招募3 期
Randomized, controlled growth hormone study in children and adolescents with a Prader-Willi-like phenotype, followed by a two year open-label growth hormone study - effects on body composition, growth, psychosocial development and quality of life - Prader-Willi-like (PWL) study
Stichting Kind en Groei0 个研究点目标入组 64 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 64
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 2 至 17（—）
入选标准
- •- Prader-Willi-like phenotype, according to the PWL criteria (see below), or
- •with a proven molecular diagnosis of a uniparental disomy of chromosome 14
- •(mUPD14), or a mutation or duplication in the 15q11.2-q13 region (PWS-critical
- •- Absence of a molecular diagnosis of PWS. This includes a type 1 (from
- •breakpoint 1 to breakpoint 4) or type 2 (from breakpoint 2 to breakpoint 4)
- •deletion, a uniparental disomy or imprinting center defect of the 15q11.2-q13
- •o Boys: 4 to 16 years
- •o Girls: 4 to 14 years.
- •- Written informed consent. , PWL criteria:
- •The PWL phenotype is present in case of the following symptoms:
- •Hyperphagia and/or rapid weight gain between the ages of 1 and 8 years
- •Developmental/psychomotor delay (IQ<85 and/or enrolment in a school for
- •children with special needs)
- •One or more of the following symptoms:
- •o Infantile central hypotonia
- •o Behavioural problems (temper tantrums, (auto)aggression, autistic and/or
- •obsessive compulsive behaviour
- •o Poor speech
- •o Vision abnormalities (e.g. myopia, esotropia)
- •o Short stature (as defined by < -2SD-score, or -2SD relative to the target
- •o Small hands and feet for height and/or age.
- •N.B. Patients diagnosed with UPD14 or a mutation/duplication in the 15q11.2
- •(Prader-Willi critical) region do not have to meet the PWL-criteria.
排除标准
- •- Non-cooperative behavior
- •- Extremely low dietary intake of less than the minimally required intake
- •according to WHO
- •- Use of medication to reduce weight
- •- BMI > +4SD
- •- Height velocity <1 cm per year and/or closed epiphyseal growth plates, as
- •determined by an x-ray of the hand
- •- Pregnancy
研究者
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