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Retrospective Study Of The Influence Of Age At Start Of Growth Hormone Treatment On Height Gain In Children Born Small for Gestational Age (GH-RAST)

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ClinicalTrials.gov Identifier: NCT01897753
Recruitment Status : Completed
First Posted : July 12, 2013
Last Update Posted : January 20, 2014
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
The purpose of this protocol is to retrospectively study the influence of age at start of growth hormone (GH) treatment on height gain in children born small for gestational age (SGA).

Condition or disease Intervention/treatment
Small For Gestational Age (SGA) Drug: growth hormone

Study Type : Observational
Actual Enrollment : 264 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Retrospective Study Of The Influence Of Age At Start Of Growth Hormone (Gh) Treatment On Height Gain In Children Born Small for Gestational Age (SGA)
Study Start Date : March 2012
Actual Primary Completion Date : September 2013
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones

Group/Cohort Intervention/treatment
Small For Gestational Age (SGA) Children
SGA children under growth hormone treatment for more than 36 months.
Drug: growth hormone
36 months




Primary Outcome Measures :
  1. height SDS [ Time Frame: 36 months ]
    height SDS of SGA children after 36 months of treatment


Secondary Outcome Measures :
  1. height increase [ Time Frame: 36 months ]
  2. Change from Baseline in Lipid Parameters at Month X [ Time Frame: 36 months ]
    Mean Total Cholesterol (TC), Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL), and Triglyceride blood concentrations.



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Ages Eligible for Study:   4 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
SGA children treated with GH at least 36 months
Criteria

Inclusion Criteria:

  • SGA children.

    • Treated with GH at least 36 months.

Exclusion Criteria:

  • Patients treated with GH for other indications (not SGA).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01897753


Locations
Spain
H. Germans Trias i Pujol
Badalona, Barcelona, Spain, 8916
H. Sant Joan de Déu
Esplugues de Llobregat, Barcelona, Spain, 8950
H.Marqués de Valdecilla
Santander, Cantabria, Spain, 39008
Hospital Virgen de la Arrixaca
El Palmar, Murcia, Spain, 30120
Hospital Virgen del Camino
Pamplona, Navarra, Spain, 31008
Capio H.Universitario Sagrat Cor
Barcelona, Spain, 8029
H. Vall d'Hebron
Barcelona, Spain, 8035
H.Gregorio Marañón
Madrid, Spain, 28007
Hospital La Paz
Madrid, Spain, 28046
Hospital Carlos Haya
Málaga, Spain, 18012
H.Clinico Universitario Valladolid
Valladolid, Spain, 47003
Hospital Universitario Miguel Servet
Zaragoza, Spain, 50009
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01897753     History of Changes
Other Study ID Numbers: A6281310
First Posted: July 12, 2013    Key Record Dates
Last Update Posted: January 20, 2014
Last Verified: January 2014

Keywords provided by Pfizer:
SGA
Growth hormone

Additional relevant MeSH terms:
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs