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 | ||||
|---|---|---|---|---|
| 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 |
| |||
| 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 |
| |||
| 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 |
| |||
| 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 | ||||