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

Small For Gestational Age (SGA) Clinical Trial

— GH-RAST  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01897753
• Other study ID #: A6281310
• Status: Completed
• Phase: Phase 4
• First received: July 9, 2013
• Last updated: January 17, 2014
• Start date: March 2012
• Est. completion date: September 2013

Study information

• Verified date: January 2014
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 264
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years and older

Eligibility

Inclusion Criteria:

• SGA children.

• Treated with GH at least 36 months.

Exclusion Criteria:

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

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Small For Gestational Age (SGA)

Intervention

Drug:
• growth hormone
36 months

Locations

Country	Name	City	State
Spain	H. Germans Trias i Pujol	Badalona	Barcelona
Spain	Capio H.Universitario Sagrat Cor	Barcelona
Spain	H. Vall d'Hebron	Barcelona
Spain	Hospital Virgen de la Arrixaca	El Palmar	Murcia
Spain	H. Sant Joan de Déu	Esplugues de Llobregat	Barcelona
Spain	H.Gregorio Marañón	Madrid
Spain	Hospital La Paz	Madrid
Spain	Hospital Carlos Haya	Málaga
Spain	Hospital Virgen del Camino	Pamplona	Navarra
Spain	H.Marqués de Valdecilla	Santander	Cantabria
Spain	H.Clinico Universitario Valladolid	Valladolid
Spain	Hospital Universitario Miguel Servet	Zaragoza

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	height SDS	height SDS of SGA children after 36 months of treatment	36 months	No
Secondary	height increase		36 months	No
Secondary	Change from Baseline in Lipid Parameters at Month X	Mean Total Cholesterol (TC), Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL), and Triglyceride blood concentrations.	36 months	No

External Links

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