Growth Hormone in Children Under 2 Years With Prader-Willi in Hospital of Sabadell
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ClinicalTrials.gov Identifier: NCT02205450 |
Recruitment Status :
Completed
First Posted : July 31, 2014
Last Update Posted : March 31, 2022
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Tracking Information | ||||
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First Submitted Date | July 30, 2014 | |||
First Posted Date | July 31, 2014 | |||
Last Update Posted Date | March 31, 2022 | |||
Study Start Date | September 2014 | |||
Actual Primary Completion Date | July 29, 2019 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures |
To assess the safe use of GH in children under 2 year old with Prader Willi Syndrome [ Time Frame: Two years ] Collect any Serious Adverse Event during the length of study
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Original Primary Outcome Measures | Same as current | |||
Change History | ||||
Current Secondary Outcome Measures |
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Original Secondary Outcome Measures | Same as current | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title | Growth Hormone in Children Under 2 Years With Prader-Willi in Hospital of Sabadell | |||
Official Title | Experience With Growth Hormone (GH) in Children Under 2 Years With Prader-Willi Syndrome (PWS) in the Pediatric Endocrine Department of the Hospital of Sabadell | |||
Brief Summary | The PWS is a genetic disease with intellectual disabilities associated with multiple manifestations in other body systems. It is characterized by hypothalamic-pituitary abnormalities with severe hypotonia during the early years of life, conditioning feeding difficulties. Hyperphagia appears later, causing severe obesity in pre - school ages. Other endocrine abnormalities associated produce short stature, GH deficiency and hypogonadotropic hypogonadism. These patients also have varying cognitive dysfunction associated as well as learning problems, compounded by the development of psychological-psychiatric and behavioral problems language. The aetiology of GH decreased secretion of the SPW is controversial, it is known that IGF -1 levels are reduced in children and adults with PWS. The rational use of GH is derived from knowledge of comorbidities observed in PWS, which seem to be related to GH deficiency: hypotonia, altered body composition, decreased growth, even obesity. • The GH is accepted since 2000 for the treatment of PWS. Following fatal episodes in our country, it was decided to start treatment at 2 years of age in an arbitrary manner, but not in the U.S. or France. Subsequent studies have found that GH per se is not a risk factor for mortality. The currently published data supporting the benefits of GH treatment when started between 4 and 6 months of life, even some experts advocate starting at 3 months, but due to the lack of consensus on the age of onset treatment, despite the benefits of your home at an early age before the onset of obesity often starts around 2 years of life. HYPOTHESIS The use of GH is safe and effective in patients with PWS children under 2 years old. |
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Detailed Description | Not Provided | |||
Study Type | Observational | |||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | |||
Biospecimen | Not Provided | |||
Sampling Method | Non-Probability Sample | |||
Study Population | Hospitalary population | |||
Condition | Prader-Willi Syndrome | |||
Intervention | Drug: Recombinant Somatropin | |||
Study Groups/Cohorts | Children under 2 years with Prader-Willi Syndrome
Intervention: Drug: Recombinant Somatropin
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status | Completed | |||
Actual Enrollment |
16 | |||
Original Estimated Enrollment |
15 | |||
Actual Study Completion Date | July 29, 2019 | |||
Actual Primary Completion Date | July 29, 2019 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria: - |
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Sex/Gender |
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Ages | 3 Months to 2 Years (Child) | |||
Accepts Healthy Volunteers | No | |||
Contacts | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries | Spain | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number | NCT02205450 | |||
Other Study ID Numbers | CPT_ENDOPED201401 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Current Responsible Party | Raquel Corripio-Collado, Corporacion Parc Tauli | |||
Original Responsible Party | Same as current | |||
Current Study Sponsor | Corporacion Parc Tauli | |||
Original Study Sponsor | Same as current | |||
Collaborators | Not Provided | |||
Investigators |
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PRS Account | Corporacion Parc Tauli | |||
Verification Date | March 2022 |