Genotropin Treatment In Very Young Children Born Small For Gestational Age
NCT00627523
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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.
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.
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Descriptive Information | ||||
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Brief Title ICMJE | Genotropin Treatment In Very Young Children Born Small For Gestational Age | |||
Official Title ICMJE | 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) | |||
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. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE | Infant, Small for Gestational Age | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | De Schepper J, Vanderfaeillie J, Mullis PE, Rooman R, Robertson A, Dilleen M, Gomez R, Wollmann HA. A 2-year multicentre, open-label, randomized, controlled study of growth hormone (Genotropin®) treatment in very young children born small for gestational age: Early Growth and Neurodevelopment (EGN) Study. Clin Endocrinol (Oxf). 2016 Mar;84(3):353-60. doi: 10.1111/cen.12968. Epub 2015 Nov 25. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 43 | |||
Original Estimated Enrollment ICMJE | 88 | |||
Actual Study Completion Date ICMJE | December 2013 | |||
Actual Primary Completion Date | December 2013 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | 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. | |||
Sex/Gender ICMJE |
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Ages ICMJE | 19 Months to 29 Months (Child) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Belgium, Czech Republic, France, Germany, Italy, Netherlands, Spain, Sweden, Switzerland | |||
Removed Location Countries | Austria, Luxembourg, United Kingdom | |||
Administrative Information | ||||
NCT Number ICMJE | NCT00627523 | |||
Other Study ID Numbers ICMJE | A6281287 2007-003949-32 ( EudraCT Number ) SGA ( Other Identifier: Alias Study Number ) | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Pfizer | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Pfizer | |||
Verification Date | October 2014 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |