EUCTR2005-001507-19-IE
Active, not recruiting
Phase 1
Treatment with recombinant Growth Hormone in Children born Small for Gestational Age (SGA) without Catch-up Growth. - Not applicable
ational Children's Hospital & Trinity College Dublin0 sites350 target enrollmentApril 7, 2005
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Short stature in children born small for gestational age without catch up growth
- Sponsor
- ational Children's Hospital & Trinity College Dublin
- Enrollment
- 350
- Status
- Active, not recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Small for gestational age (BW \< \- 2SD below mean according to standard references)
- •Gestational age at birth more than 28 weeks
- •Short at 4 years of age (Height SDS \<\-2\.5 according to standard references)
- •Short for parental height (HSDS \> 1 SD below parental adjusted HSDS)
- •Age 4\-8 years (girls) and 4\-9 years (boys)
- •Pre\-pubertal at start of treatment (testis volume \< 4ml, breast stage 1\)
- •Height records must be available for 6 months prior to inclusion in the study
- •Height velocity SDS \< 0 during last 6 months (according to country specific references)
- •No previous growth hormone therapy.
- •Are the trial subjects under 18? yes
Exclusion Criteria
- •Known or suspected allergy to growth hormone
- •Previous participation in growth hormone trial
- •Severe mental retardation as judged by the investigation
- •Previous or active malignancy
- •Benign intracranial hypertension (present or past)
- •Diabetes mellitus
- •Growth retardation due to chronic diseases including hypertension, asthma (if on inhaled corticosteroids \>800µg/day), syndromes (like fetal alcohol syndrome) and chromosomal anomalies (except Silver Russell syndrome).
- •Psychological problems likely to lead to significant non\-compliance.
Outcomes
Primary Outcomes
Not specified
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