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

Completed

• Conditions: Small For Gestational Age (SGA)
• Interventions: Drug: growth hormone

• Registration Number: NCT01897753
• Lead Sponsor: 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2013-07-09
• Study First Submitted QC: 2013-07-09
• Study First Posted: 2013-07-12
• Primary Completion: 2013-09
• Study Completion: 2013-09
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-17
• Last Update Posted: 2014-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 264

Inclusion Criteria

• SGA children.

  • Treated with GH at least 36 months.

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
height SDS	36 months	height SDS of SGA children after 36 months of treatment

Secondary Outcome Measures

Name	Time	Method
height increase	36 months
Change from Baseline in Lipid Parameters at Month X	36 months	Mean Total Cholesterol (TC), Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL), and Triglyceride blood concentrations.

Trial Locations

Locations (12)

Hospital Virgen de la Arrixaca; 🇪🇸 El Palmar, Murcia, Spain

H.Marqués de Valdecilla; 🇪🇸 Santander, Cantabria, Spain

H. Germans Trias i Pujol; 🇪🇸 Badalona, Barcelona, Spain

Hospital Carlos Haya; 🇪🇸 Málaga, Spain

H. Sant Joan de Déu; 🇪🇸 Esplugues de Llobregat, Barcelona, Spain

Capio H.Universitario Sagrat Cor; 🇪🇸 Barcelona, Spain

Hospital Virgen del Camino; 🇪🇸 Pamplona, Navarra, Spain

H. Vall d'Hebron; 🇪🇸 Barcelona, Spain

Hospital La Paz; 🇪🇸 Madrid, Spain

H.Gregorio Marañón; 🇪🇸 Madrid, Spain

H.Clinico Universitario Valladolid; 🇪🇸 Valladolid, Spain

Hospital Universitario Miguel Servet; 🇪🇸 Zaragoza, Spain