EUCTR2013-003100-39-NL进行中（未招募）不适用
Standardized versus individualized growth hormone treatment of shortchildren born small for gestational age: Effects on short-term and longtermefficacy, long-term psychosocial development, glucose metabolismand body composition. - National SGA study
Dutch Growth Research Foundation0 个研究点开始时间: 2013年8月15日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Children born with a birth length and/or weight <-2 SD for gestational age (Niklasson, (48).
- •Short stature defined as height SD score <-2.5 according to the Dutch National Growth References of 1997 (49).
- •Height of =1 SD score below target height SD score (TH SDS).
- •Height velocity (cm/year) for chronological age =0 SDS in prepubertal children (50).
- •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.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 300
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 300
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
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, (51)), 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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Standardized versus individualized growth hormone treatment of short children born small for gestational age: Effects on short-term and long-term efficacy, long-term psychosocial development, glucose metabolism and body composition.dysmaturitysmall for gestational age10052547NL-OMON39333Stichting Kind en Groei200
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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.dysmaturitysmall for gestational age10052547NL-OMON38571Dutch Growth Research Foundation300
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