Status:
COMPLETED
Genotropin Treatment In Very Young Children Born Small For Gestational Age
Lead Sponsor:
Pfizer
Conditions:
Infant, Small for Gestational Age
Eligibility:
All Genders
19-29 years
Phase:
PHASE3
Brief Summary
To demonstrate the effect on height and psychomotor development of Growth Hormone treatment in very young children starting at an age of 2 years.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT00627523
Start Date
February 1 2008
End Date
December 1 2013
Last Update
November 4 2014
Active Locations (17)
Enter a location and click search to find clinical trials sorted by distance.
1
Universitair Ziekenhuis Brussel/Pediatrie
Brussels, Belgium, 1090
2
Universitair Ziekenhuis Antwerpen / Pediatrie
Edegem, Belgium, 2650
3
Fakultni nemocnice Olomouc
Olomouc, Czechia, 775 20
4
Fakultni nemocnice Ostrava, Detska klinika
Ostrava-Poruba, Czechia, 708 52