Treatment with recombinant Growth Hormone in Children born Small for Gestational Age (SGA) without Catch-up Growth. - Not applicable

Phase 1

• Conditions: Short stature in children born small for gestational age without catch up growth

• Registration Number: EUCTR2005-001507-19-IE
• Lead Sponsor: ational Children's Hospital & Trinity College Dublin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-04-07
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 350

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
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified