ISRCTN96883876
Completed
未知
Growth hormone treatment of children after IntraUterine Growth Retardation: IUGR-2 study
Erasmus Medical Centre (The Netherlands)0 sites170 target enrollmentJanuary 27, 2006
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Erasmus Medical Centre (The Netherlands)
- Enrollment
- 170
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Birth weight less than P3 for gestational age (according to Usher and McLean)
- •2\. Neonatal period without signs of severe asphyxia (defined by Apgar score less than 3 after 5 minutes), without signs of chronic lung disease (such as bronchopulmonary dysplasia)
- •3\. No catch\-up growth defined as obtaining a height of P3 within the first 2 years of life or at a later stage
- •4\. Height velocity (cm/year) for chronological age P50
- •5\. Chronological age at the start of treatment: 3\.0 \- 7\.99 years (boys and girls)
- •6\. Prepubertal signs defined as Tanner stage 1 or testicular volume less than 4 ml
- •7\. Well documented growth data from birth up to 2 years and at least 1 year before the start of the study
Exclusion Criteria
- •1\. Any endocrine or metabolic disorder such as diabetes mellitus, diabetes insipidus, hypothyroidism or inborn errors of metabolism, except of GHD
- •2\. Disorders of genito\-urinary tract, cardiopulmonary or gastrointestinal tract, or nervous systems, nutritional and/or vitamin deficiencies
- •3\. Chromosomal abnormalities or signs of a syndrome, except of Silver\-Russell Syndrome (SRS)
- •4\. Chondrodysplasia
- •5\. Hydrocephalus
- •6\. Active malignancy or increased risk of leukaemia
- •7\. Serious suspicion of psychosocial dwarfism (emotional deprivation)
- •8\. Previous anabolic sex steroid or GH therapy
Outcomes
Primary Outcomes
Not specified
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