NL-OMON24733招募中不适用
Efficacy and safety of growth hormone treatment in short children born small for gestational age (IUGR-3 STUDY); Effects of GH-levels on growth, insulin sensitivity and body composition.
Erasmus Medical Center/ Sophia Children's HospitalPO Box 20603000 CB RotterdamThe NetherlandsTel: +31 10 463 63 630 个研究点目标入组 157 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 157
研究概览
简要总结
van Dijk M, Mulder P, Houdijk M, et al. High Serum Levels of Growth Hormone (GH) and IGF-I during High Dose Growth Hormone Treatment in Short Children Born Small for Gestational Age. J Clin Endocrinol Metab 2006
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Children born with a birth length and/or weight < - 2 SD for gestational age (Usher McLean (22));
- •2. Neonatal period without signs of severe asphyxia (defined as Apgar score < 3 after 5 minutes), and no serious diseases such as long-term artificial ventilation and oxygen supply, broncho pulmonary dysplasia or other chronic lung disease;
- •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 £ P50 (25);
- •5. Chronological age at start of treatment: 3.00 - 7.99 years (boys and girls);
- •6. Prepubertal signs defined as Tanner stage 1 or testicular volume < 4 ml (26);
- •7. Well documented growth data from birth up to 2 years and at least 1 year before the start of the study;
- •8. Both growth hormone deficient and growth hormone insufficient patients;
- •9. Informed consent.
排除标准
- •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, genito-urinary tract, liver, lungs, skeleton or central nervous system, metabolic disease or 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 of GHD;
- •4. Use of medications or interventions at this moment or 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);
- •5. Active malignancy or increased risk of leukaemia;
- •6. Serious suspicion of psychosocial dwarfism (emotional deprivation);
- •7. Expected non-compliance.
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