Genotropin Treatment In Very Young Children Born Small For Gestational Age
Information source: Pfizer
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Infant, Small for Gestational Age
Intervention: Genotropin (PN-180,307) Somatropin (Drug); Control-no treatment (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Pfizer Official(s) and/or principal investigator(s): Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
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.
Clinical Details
Official title: 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)
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Change From Baseline in Height Standard Deviation Score (SDS) at Month 24.
Secondary outcome: Change From Baseline in Growth Velocity SDS at Month 24.Change From Baseline in Height SDS at Month 12. Change From Baseline in Growth Velocity SDS at Month 12. Change From Baseline in Mental Development Using the Mental Development Index (MDI) of Bayley Scale at Month 12. Change From Baseline in Psychomotor Development Using the Psychomotor Development Index (PDI) of Bayley Scale at Month 12. Head Circumference SDS at Months 3, 6, 12, 18 and 24. Change From Baseline in Head Circumference SDS at Months 3, 6, 12, 18 and 24. Change From Baseline in Body Weight at Months 3, 6, 12, 18, and 24. Change From Baseline in Body Mass Index (BMI) at Months 3, 6, 12, 18, and 24.
Eligibility
Minimum age: 19 Months.
Maximum age: 29 Months.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Universitair Ziekenhuis Brussel/Pediatrie, Brussel 1090, Belgium
Universitair Ziekenhuis Antwerpen / Pediatrie, Edegem 2650, Belgium
Fakultni nemocnice Olomouc, Olomouc 775 20, Czech Republic
Fakultni nemocnice Ostrava, Detska klinika, Ostrava-Poruba 708 52, Czech Republic
Fakultni nemocnice v Motole, Praha 5 150 06, Czech Republic
CHU Toulouse, Hôpital des Enfants, Service Endocrinologie, Toulouse Cedex 9 31059, France
Universitaetsklinikum Erlangen, Kinder- und Jugendklinik, Erlangen 91054, Germany
Centro di Endocrinologia Pediatrica, Dipartimento di Pediatria, Catania 95125, Italy
Policlinico Universitario, Istituto di Clinica Pediatrica, Messina 98100, Italy
Dipartimento Materno Infantile, UO di Pediatria e Neonatologia, Milano 20132, Italy
Dipartimento di Medicina Pediatrica, UO di Endocrinologia e Diabetologia, Roma 00165, Italy
Sophia Children's Hospital, Rotterdam 3015 GJ, Netherlands
Hospital Miguel Servet, Zaragoza 50009, Spain
Drottning Silvias Barn och Ungdomssjukhus, Göteborg, Sweden
Inselspital, CH-3010 Bern, Switzerland
Consorci Hospitalari Parc Tauli, Sabadell, Barcelona 08208, Spain
Hospital Virgen Del Camino, Pamplona, Navarra 31008, Spain
Additional Information
To obtain contact information for a study center near you, click here.
Starting date: February 2008
Last updated: October 27, 2014
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