Efficacy and safety of growth hormone treatment in short children born small for gestational age; effects of growth hormone levels on growth, insulin sensitivity and body composition

Erasmus Medical Center (The Netherlands)0 个研究点目标入组 157 人开始时间: 2006年7月19日最近更新: 2017年2月6日

适应症

试验速览

暂无简介。

•1. Children born with a birth length and/or weight <2 standard devations (SD) for gestational age (Usher McLean)
•2. Neonatal period without signs of severe asphyxia (defined as Apgar score <3 after five minutes), and no serious diseases such as long-term artificial ventilation and oxygen supply, bronchopulmonary dysplasia or other chronic lung diseases
•3. Short stature defined as a height SD score below 2.5 according to the Dutch National Growth references of 1997
•4. Height velocity (cm/year) for chronological age
•5. Chronological age at the start of treatment: 3.00 - 7.99 years (boys and girls)
•6. Prepubertal signs defined as Tanner stage 1 or testicular volume <4 ml
•7. Well documented growth data from birth up to two years and at least one year before the start of the study
•8. Both growth hormone deficient and growth hormone insufficient patients
•9. Informed consent

•1. Chromosomal disorders, known syndromes and serious dysmorphic symptoms suggestive for a syndrome that has not yet been described, except for Silver Russell syndrome
•2. Coeliac disease and other chronic or serious diseases of the gastrointestinal tract, heart, genitourinary tract, liver, lungs, skeleton, central nervous system, metabolic disease, chronic or recurrent major infectious diseases, nutritional and/or vitamin deficiencies
•3. Any endocrine or metabolic disorder such as diabetes mellitus, diabetes insipidus, hypothyroidism, or inborn errors of metabolism, except for growth hormone deficiency (GHD)
•4. Use of medications or interventions at this moment or during the previous six 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)
•5. Active malignancy or increased risk of leukaemia
•6. Serious suspicion of psychosocial dwarfism (emotional deprivation)
•7. Expected non-compliance

发起方

Erasmus Medical Center (The Netherlands)