Small For Gestational Age (SGA)GH-RASTNCT01897753
Retrospective Study Of The Influence Of Age At Start Of Growth Hormone Treatment On Height Gain In Children Born Small for Gestational Age
An observational study of Small For Gestational Age (SGA), run by Pfizer at 12 sites in Spain.
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). Read more about this study
- Who is it for?
- Ages 4 years and older
- Conditions the study is for
- Small For Gestational Age (SGA)
- What is being tested?
- growth hormone
- How many people
- 264 participants
- Where
- 12 sitesSpain
- Study dates
- Mar 2012to Sep 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: SGA children treated with GH at least 36 months
Who may be able to join
- SGA children.
- Treated with GH at least 36 months.
Who cannot join
- Patients treated with GH for other indications (not SGA).
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Spain12 sites
H. Germans Trias i Pujol
Badalona, Barcelona, 8916
Capio H.Universitario Sagrat Cor
Barcelona, Barcelona, 8029
H. Vall d'Hebron
Barcelona, Barcelona, 8035
Hospital Virgen de la Arrixaca
El Palmar, Murcia, 30120
H. Sant Joan de Déu
Esplugues de Llobregat, Barcelona, 8950
H.Gregorio Marañón
Madrid, Madrid, 28007
Hospital La Paz
Madrid, Madrid, 28046
Hospital Carlos Haya
Málaga, Málaga, 18012
Hospital Virgen del Camino
Pamplona, Navarre, 31008
H.Marqués de Valdecilla
Santander, Cantabria, 39008
H.Clinico Universitario Valladolid
Valladolid, Valladolid, 47003
Hospital Universitario Miguel Servet
Zaragoza, Zaragoza, 50009
About this study
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)
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).
- Conditions
- Small For Gestational Age (SGA)
- Being tested
- growth hormone
- Keywords
- SGA, Growth hormone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
growth hormoneDrug
36 months
| Study group | Role | What they receive |
|---|---|---|
| Small For Gestational Age (SGA) Children | SGA children under growth hormone treatment for more than 36 months. Receives: Drug: growth hormone |
What is being measured
The primary outcome is the main question the study is designed to answer.
height SDS
height SDS of SGA children after 36 months of treatment
Measured: 36 months
Secondary outcomes (2)
height increase
Measured: 36 months
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.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2013 (estimated)
- Study startMar 2012
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small For Gestational Age (SGA)Studies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 264 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01897753
- Sponsor's protocol ID
- A6281310
- Acronym
- GH-RAST
- Status last verified
- Jan 2014
- First submitted
- 9 Jul 2013
- Last updated
- 20 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01897753
- Acronym / sponsor ID
- GH-RAST / A6281310
- Conditions
- Small For Gestational Age (SGA)
- Keywords
- SGA, Growth hormone
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 264 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 12 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Small For Gestational Age (SGA) Children | – | Drug: growth hormoneSGA children under growth hormone treatment for more than 36 months. |
Who may qualify
- Ages
- 4 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- SGA children treated with GH at least 36 months
Key inclusion criteria (2 listed)
- SGA children.
Key exclusion criteria (1 listed)
- Patients treated with GH for other indications (not SGA).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| growth hormone36 months | Drug | Small For Gestational Age (SGA) Children |
Primary outcome
height SDS
Time frame: 36 months
height SDS of SGA children after 36 months of treatment
2 secondary outcomes
height increase
Time frame: 36 months
Change from Baseline in Lipid Parameters at Month X
Time frame: 36 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2014.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Related trials for Small For Gestational Age (SGA)
Enrolling by invitationObservational study
Influence of Adherence to Growth Hormone Therapy (GHT) With Norditropin® on Near Final Height in Patients With Growth Hormone Deficiency (GHD) and Born Small for Gestational Age (SGA)
Growth Hormone Deficiency in Children, Born Small for Gestational Age
Active, not recruitingPhase 2
A Research Study in Children Born Small and Who Stayed Small. Treatment is Somapacitan Once a Week Compared to Norditropin® Once a Day
Short Stature Children Born Small for Gestational Age (SGA)
Not yet recruitingPhase 3
A Phase III Clinical Study of Jinpei Growth Hormone Injection in the Treatment of Short Stature Children With Small for Gestational Age (SGA)
Small for Gestational Age
Active, not recruitingPhase 3
A Research Study Looking at How Safe Somapacitan is and How Well it Works in Children Who Need Help to Grow - REAL 9
SGA, Turner Syndrome
Active, not recruitingPhase 3
A Research Study to Compare Somapacitan Once a Week With Norditropin® Once a Day in Children Who Need Help to Grow
SGA, Turner Syndrome, Noonan Syndrome, ISS
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Small For Gestational Age (SGA), run by Pfizer at 12 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
height SDS (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2014.