ational SGA study

• Conditions: Children who are born small for gestational age, defined as a birth lengthand/or birth weight < -2 SD score, who fail to show catch-up growth(short stature).; MedDRA version: 16.0Level: LLTClassification code 10018747Term: Growth hormoneSystem Organ Class: 100000004848; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: EUCTR2013-003100-39-NL
• Lead Sponsor: Dutch Growth Research Foundation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08-15
• Last Update Posted: 9 December 2013

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Children born with a birth length and/or weight <-2 SD for gestational age (Niklasson, (48).
• Short stature defined as height SD score <-2.5 according to the Dutch National Growth References of 1997 (49).
• Height of =1 SD score below target height SD score (TH SDS).
• Height velocity (cm/year) for chronological age =0 SDS in prepubertal children (50).
• 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.

Are the trial subjects under 18? yes
Number of subjects for this age range: 300
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 300
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• 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 the DSM IV.
• Complicated neonatal period, including signs of severe asphyxia (defined as an Apgar score <3 after 5 minutes, (51)), severe sepsis with multiple organ failure (MOF), long term artificial ventilation and oxygen supply and/or bronchopulmonary dysplasia.
• 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 such as diabetes mellitus, diabetes insipidus, hypothyroidism, or inborn errors of metabolism, except for growth hormone deficiency (GHD).
• Genetic alterations (e.g. mutations, deletions) in the IGF-I receptor gene.
• Medications or interventions during the previous 6 months that might have interfered with growth, such as corticosteroids (including high dose of corticosteroids inhalation), sex steroids, growth hormone, or major surgery (particularly of the spine and extremities).
• Use of medication that might interfere with growth during GH therapy, such as corticosteroids and sex steroids.
• Active or treated malignancy or increased risk of leukaemia.
• Serious suspicion of psychosocial dwarfism (emotional deprivation).
• Expected non-compliance.

Study & Design

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