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

Last updated on November 14, 2019

FOR MORE INFORMATION
Study Location
H. Germans Trias i Pujol
Badalona, Barcelona, 8916 Spain
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Small For Gestational Age (SGA)
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
4 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- SGA children.

- Treated with GH at least 36 months.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

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

NCT01897753
Pfizer
Completed
Retrospective Study Of The Influence Of Age At Start Of Growth Hormone Treatment On Height Gain In Children Born Small for Gestational Age

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Descriptive Information
Brief TitleRetrospective Study Of The Influence Of Age At Start Of Growth Hormone Treatment On Height Gain In Children Born Small for Gestational Age
Official TitleRetrospective Study Of The Influence Of Age At Start Of Growth Hormone (Gh) Treatment On Height Gain In Children Born Small for Gestational Age (SGA)
Brief SummaryThe 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 DescriptionNot Provided
Study TypeObservational
Study DesignObservational Model: Case-Only
Time Perspective: Retrospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodNon-Probability Sample
Study PopulationSGA children treated with GH at least 36 months
ConditionSmall For Gestational Age (SGA)
InterventionDrug: growth hormone
36 months
Study Groups/CohortsSmall For Gestational Age (SGA) Children
SGA children under growth hormone treatment for more than 36 months.
Intervention: Drug: growth hormone
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment StatusCompleted
Actual Enrollment
 (submitted: January 17, 2014)
264
Original Estimated Enrollment
 (submitted: July 9, 2013)
300
Actual Study Completion DateSeptember 2013
Actual Primary Completion DateSeptember 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • SGA children.

    • Treated with GH at least 36 months.

Exclusion Criteria:

  • Patients treated with GH for other indications (not SGA).
Sex/Gender
Sexes Eligible for Study:All
Ages4 Years and older   (Child, Adult, Older Adult)
Accepts Healthy VolunteersNo
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesSpain
Removed Location Countries  
 
Administrative Information
NCT NumberNCT01897753
Other Study ID NumbersA6281310
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing StatementNot Provided
Responsible PartyPfizer
Study SponsorPfizer
CollaboratorsNot Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateJanuary 2014

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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