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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

Page last updated: August 20, 2015

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