A two-year multi-centre, randomized two arm study of Genotropin treatment in very young children born small for gestational age: Early Growth and Neurodevelopment (EGN) - Not Applicable

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 43

Inclusion Criteria

Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study:

1. Male or female subjects aged between 19-29 months at Screening Visit 1.
2. Signed and dated informed consent.
3. Born SGA (birth length and/or weight <-2 SD for gestational age, using country-specific standards).
4. Height below -2.5 SD at screening (19-29 months of age).
5. At least one measurement of length between 12 and 18 months of age.
6. Normal karyotype in girls to exclude Turners syndrome.
7. Screening laboratory values within normal limits, or abnormalities clinically insignificant in the judgement of the investigator.
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

Subjects presenting with any of the following will not be included in the study:
1. Severe Intra-Uterine Growth Retardation (IUGR) (birth length below - 4 SD for gestational age), if associated with dysmorphic features.
2. Severe prematurity (Gestational Age (GA) <32 weeks of gestation).
3. Ongoing catch-up growth (defined as growth velocity SDS at inclusion >0) based on at least 4 months measurement interval).
4. Severe familial short stature defined as: Father’s height below 155 cm or mother’s height below 145 cm.
5. Defined neurological defects and/or severe neurodevelopmental delay.
6. Defined syndromes such as fetal alcohol syndrome.
7. Severe perinatal complications like asphyxia, sepsis, Necrotizing Enterocolitis (NEC), respiratory distress syndrome, if associated with long-term sequelae (like short bowel syndrome, Broncho Pulmonary Dysplasia (BPD), cerebral palsy etc).
8. Other specific reason for short stature (eg, osteochondrodysplasia).
9. Any severe, acute or chronic illness (neurological, respiratory, gastrointestinal (eg, Coeliac disease etc) which in the opinion of the investigator may interfere with the interpretation of safety or efficacy evaluations.
10. Will be unlikely to comply with the protocol eg, inability to return for follow-up visits, or is unlikely to complete the study.
11. Is participating in any other studies involving investigational or marketed products.
12. Is currently treated with systemic glucocorticoids or has been treated with glucocorticoids for a period of one week or longer in the past 6 months. Topical or inhaled corticosteroids are permitted.
13. Subjects receiving other hormone treatment are not eligible for this study (except stable thyroid hormone replacement).
14. Any patient who meets any contraindication specified in the Genotropin SmPC, such as hypersensitivity to the active substance or to any of the excipients or any evidence of tumor activity.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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