A Two Year Multicentre, Randomized Two Arm Study Of Genotropin Treatment In Very Young Children Born Small For Gestational Age: Early Growth And Neurodevelopment(Egn)
A Two Year Multicentre, Randomized Two Arm Study Of Genotropin Treatment In Very Young Children Born Small For Gestational Age: Early Growth And Neurodevelopment(Egn)
To demonstrate the effect on height and psychomotor development of Growth Hormone treatment in very young children starting at an age of 2 years.
Inclusion Criteria:
Caucasian male or female subjects aged between 19-29 months at Screening Visit 1.
Born SGA (birth length and/or weight <-2 SD for gestational age, using country-specific standards).
Height below -2.5 SD at screening (19-29 months of age). At least one measurement of length between 12 and 18 months of age. Normal karyotype in girls to exclude Turners syndrome.
Exclusion Criteria:
Severe Intra-Uterine Growth Retardation (IUGR) (birth length below - 4 SD for gestational age), if associated with dysmorphic features.
Severe prematurity (Gestational Age (GA) <32 weeks of gestation). Ongoing catch-up growth (defined as growth velocity SDS at inclusion >0) based on at least 4 months measurement interval).
Severe familial short stature defined as: Father's height below 155 cm or mother's height below 145 cm.
Defined neurological defects and/or severe neurodevelopmental delay.
Ostrava-Poruba, 708 52, Czechia
Ch-3010 Bern, Switzerland