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Genotropin Treatment In Very Young Children Born Small For Gestational Age

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NCT00627523

Last updated on March 26, 2020
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Study Location
Universitair Ziekenhuis Brussel/Pediatrie
Brussel, , 1090 Belgium
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Contact
1-800-718-1021
[email protected]
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Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Small for Gestational Age Infant
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
19-29 months
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

Caucasian male or female subjects aged between 19-29 months at Screening Visit 1.

Born SGA (birth length and/or weight 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

Severe Intra-Uterine Growth Retardation (IUGR) (birth length below - 4 SD for gestational
age), if associated with dysmorphic features.

Severe prematurity (Gestational Age (GA) (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.

NCT00627523
Pfizer
Completed
Genotropin Treatment In Very Young Children Born Small For Gestational Age

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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
  • Drug: Genotropin (PN-180,307) Somatropin
    Injectable Genotropin
  • Drug: Control-no treatment
    Control-no treatment
Study Arms  ICMJE
  • Experimental: Active
    The active treatment arm
    Intervention: Drug: Genotropin (PN-180,307) Somatropin
  • Experimental: Control
    Control
    Intervention: Drug: Control-no treatment
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
 (submitted: January 21, 2014) 		43
Original Estimated Enrollment  ICMJE
 (submitted: February 22, 2008) 		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
Sexes Eligible for Study: All
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
Study Director: Pfizer CT.gov Call Center Pfizer
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

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