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)

January 17, 2014 updated by: Pfizer

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)

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

264

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

SGA children treated with GH at least 36 months

Description

Inclusion Criteria:

  • SGA children.

    • Treated with GH at least 36 months.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
height SDS
Time Frame: 36 months
height SDS of SGA children after 36 months of treatment
36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
height increase
Time Frame: 36 months
36 months
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.
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (ACTUAL)

September 1, 2013

Study Completion (ACTUAL)

September 1, 2013

Study Registration Dates

First Submitted

July 9, 2013

First Submitted That Met QC Criteria

July 9, 2013

First Posted (ESTIMATE)

July 12, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

January 20, 2014

Last Update Submitted That Met QC Criteria

January 17, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A6281310

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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