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

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01897753
• Collaborator: (none)
• Enrollment: 264
• Locations: 12
• Duration (Months): 18
• Patients Per Site: 22
• Patients Per Site Per Month: 1.2

Study Details

Study Description

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	Phase
Small For Gestational Age (SGA)	Drug: growth hormone

Study Design

• 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: Mar 1, 2012
• Actual Primary Completion Date: Sep 1, 2013
• Actual Study Completion Date: Sep 1, 2013

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. height SDS [36 months]

   height SDS of SGA children after 36 months of treatment

Secondary Outcome Measures

1. height increase [36 months]

2. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 4 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• SGA children.

• Treated with GH at least 36 months.

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	H. Germans Trias i Pujol	Badalona	Barcelona	Spain	8916
2	H. Sant Joan de Déu	Esplugues de Llobregat	Barcelona	Spain	8950
3	H.Marqués de Valdecilla	Santander	Cantabria	Spain	39008
4	Hospital Virgen de la Arrixaca	El Palmar	Murcia	Spain	30120
5	Hospital Virgen del Camino	Pamplona	Navarra	Spain	31008
6	Capio H.Universitario Sagrat Cor	Barcelona		Spain	8029
7	H. Vall d'Hebron	Barcelona		Spain	8035
8	H.Gregorio Marañón	Madrid		Spain	28007
9	Hospital La Paz	Madrid		Spain	28046
10	Hospital Carlos Haya	Málaga		Spain	18012
11	H.Clinico Universitario Valladolid	Valladolid		Spain	47003
12	Hospital Universitario Miguel Servet	Zaragoza		Spain	50009

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT01897753
• Other Study ID Numbers: A6281310
• First Posted: Jul 12, 2013
• Last Update Posted: Jan 20, 2014
• Last Verified: Jan 1, 2014

• Keywords provided by Pfizer: SGA; Growth hormone
• Additional relevant MeSH terms: Hormones

Study Results

No Results Posted as of Jan 20, 2014