Efficacy and safety of long-term growth hormone treatment In short children born small for gestational age above the age of 8 years

Dutch Growth Foundation (Netherlands)0 个研究点目标入组 107 人开始时间: 2005年12月20日最近更新: 2019年10月7日

适应症

试验速览

•1. Children born with a birth length and/or weight less than -2 SD for gestational age
•2. Short stature defined in prepubertal children as a height SD score below ?2.5 according to the Dutch National Growth References of 1997 or a predicted final height less than -2.5 SD score, calculated as the height at start of puberty plus 30 cm for boys and +20 cm for girls
•3. Height velocity (cm/year) for chronological age less than P50 in pre-pubertal children
•4. Chronological age at start of treatment: 8 years or older (boys and girls)
•5. Well documented growth data from birth up to 2 years and at least 1 year before the start of the study
•6. Informed consent

•1. Turner syndrome in girls, known syndromes and serious dysmorphic symptoms suggestive for a syndrome that has not yet been described, except for Silver Russell Syndrome
•2. Severe asphyxia (defined as Apgar score less than 3 after 5 minutes), and no serious diseases such as long-term artificial ventilation and oxygen supply, bronchopulmonary dysplasia or other chronic lung disease
•3. Coeliac disease and other chronic or serious diseases of the gastrointestinal tract, heart, genito-urinary tract, liver, lungs, skeleton or central nervous system, or chronic or recurrent major infectious diseases, nutritional and/or vitamin deficiencies
•4. Any endocrine or metabolic disorder such as diabetes mellitus, diabetes insipidus, hypothyroidism, or inborn errors of metabolism, except of GHD
•5. Medications or interventions during the previous 6 months that might have interfered with growth, such as corticosteroids (including high dose of corticosteroid inhalation), sex steroids, growth hormone, or major surgery (particularly of the spine or extremities)
•6. Use of medication that might interfere with growth during GH therapy, such as corticosteroids, sex steroids, LHRH analogue
•7. Active or treated malignancy or increased risk of leukaemia
•8. Serious suspicion of psychosocial dwarfism (emotional deprivation)
•9. Expected non-compliance

发起方

Dutch Growth Foundation (Netherlands)