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. - National SGA Study

Stichting Kind en Groei0 个研究点目标入组 200 人开始时间: 待定最近更新: 2024年5月6日

适应症

试验速览

暂无简介。

•- Children born with a birth length and/or weight < -2 SDS for gestational age (Niklasson)
•- Short stature defined as height SD score below *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.

•- 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 DSM IV.
•- Complicated neonatal period.
•- 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, except for growth hormone deficiency (GHD).
•- Genetic alterations in the IGF-I receptor gene.
•- Medications or interventions during the previous 6 months that might have interfered with growth.
•- Use of medication that might interfere with growth during growth hormone therapy.
•- Active or treated malignancy or increased risk of leukaemia.
•- Serious suspicion of psychosocial dwarfism (emotional deprivation).
•- Expected non-compliance.

发起方

Stichting Kind en Groei