NL-OMON38571尚未招募4 期
Standardized versus individualized growth hormone treatment of short children born small for gestational age: Effects on short-term and longterm efficacy, long-term psychosocial development, glucose metabolism and body composition. - National SGA study
Dutch Growth Research Foundation0 个研究点目标入组 300 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 300
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
- •Children born with a birth length and/or weight <-2 SD for gestational age (Usher and McLean)
- •Short stature defined as height SD score <-2.5 according to the Dutch National Growth References of 1997
- •Height of <=1 SD score below target height SD score (TH SDS).
- •Height velocity (cm/year) for chronological age <=0 SDS in prepubertal children
- •Chronological age at start of treatment between 4 and 11 years for boys and between 4 and 9 years for girls
- •Bone age (G&P) <=13 years for girls and <=15 years for boys
- •Well documented growth data from birth up to 2 years and at least 1 year before the start of the study.
- •Informed consent.
排除标准
- •Syndromes (except for Silver Russell Syndrome), chromosomal abnormalities and serious dysmorphic symptoms suggestive for a syndrome that has not yet been described
- •Severe psychomotor retardation according to the DSM IV
- •Complicated neonatal period, including signs of severe asphyxia (defined as an Apgar score <3 after 5 minutes, severe sepsis with multiple organ failure (MOF), long term artificial ventilation and oxygen supply and/or bronchopulmonary dysplasia
- •Celiac disease and other chronic or serious diseases of the gastro-intestinal tract, heart, genito-urinary tract, liver, lungs, skeleton or central nervous system, or chronic or recurrent major infectious diseases, nutritional and/or vitamin deficiencies
- •Any endocrine or metabolic disorder such as diabetes mellitus, diabetes insipidus, hypothyroidism, or inborn errors of metabolism, except for growth hormone deficiency (GHD)
- •Genetic alterations (e.g. mutations, deletions) in the IGF-I receptor gene
- •Medications or interventions during the previous 6 months that might have interfered with growth, such as corticosteroids (including high dose of corticosteroids inhalation), sex steroids, growth hormone, or major surgery (particularly of the spine and extremities)
- •Use of medication that might interfere with growth during GH therapy, such as corticosteroids and sex steroids
- •Active or treated malignancy or increased risk of leukaemia
- •Serious suspicion of psychosocial dwarfism (emotional deprivation)
- •Expected non-compliance
研究者
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