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
1 other identifier
observational
264
1 country
12
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2012
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2012
CompletedFirst Submitted
Initial submission to the registry
July 9, 2013
CompletedFirst Posted
Study publicly available on registry
July 12, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2013
CompletedJanuary 20, 2014
January 1, 2014
1.5 years
July 9, 2013
January 17, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
height SDS
height SDS of SGA children after 36 months of treatment
36 months
Secondary Outcomes (2)
height increase
36 months
Change from Baseline in Lipid Parameters at Month X
36 months
Study Arms (1)
Small For Gestational Age (SGA) Children
SGA children under growth hormone treatment for more than 36 months.
Interventions
Eligibility Criteria
SGA children treated with GH at least 36 months
You may qualify if:
- SGA children.
- Treated with GH at least 36 months.
You may not qualify if:
- Patients treated with GH for other indications (not SGA).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (12)
H. Germans Trias i Pujol
Badalona, Barcelona, 8916, Spain
Capio H.Universitario Sagrat Cor
Barcelona, Barcelona, 8029, Spain
H. Vall d'Hebron
Barcelona, Barcelona, 8035, Spain
H. Sant Joan de Déu
Esplugues de Llobregat, Barcelona, 8950, Spain
H.Marqués de Valdecilla
Santander, Cantabria, 39008, Spain
H.Gregorio Marañón
Madrid, Madrid, 28007, Spain
Hospital La Paz
Madrid, Madrid, 28046, Spain
Hospital Virgen de la Arrixaca
El Palmar, Murcia, 30120, Spain
Hospital Carlos Haya
Málaga, Málaga, 18012, Spain
Hospital Virgen del Camino
Pamplona, Navarre, 31008, Spain
H.Clinico Universitario Valladolid
Valladolid, Valladolid, 47003, Spain
Hospital Universitario Miguel Servet
Zaragoza, Zaragoza, 50009, Spain
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 9, 2013
First Posted
July 12, 2013
Study Start
March 1, 2012
Primary Completion
September 1, 2013
Study Completion
September 1, 2013
Last Updated
January 20, 2014
Record last verified: 2014-01