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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02205450
Recruitment Status : Unknown
Verified July 2014 by Raquel Corripio-Collado, Corporacion Parc Tauli.
Recruitment status was:  Not yet recruiting
First Posted : July 31, 2014
Last Update Posted : July 31, 2014
Sponsor:
Information provided by (Responsible Party):
Raquel Corripio-Collado, Corporacion Parc Tauli

Tracking Information
First Submitted Date July 30, 2014
First Posted Date July 31, 2014
Last Update Posted Date July 31, 2014
Study Start Date September 2014
Estimated Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 30, 2014)
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
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: July 30, 2014)
  • Evaluate the impact of treatment with GH in kids under 2 years old on body composition [ Time Frame: Every 3 months during 2 years ]
  • Evaluate the impact of treatment with GH in kids under 2 years old on start walking [ Time Frame: Every 3 months during 2 years ]
  • Evaluate the impact of treatment with GH in kids under 2 years old on the speech beginning [ Time Frame: Every 3 months during 2 years ]
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 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
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
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
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 Status Unknown status
Estimated Enrollment
 (submitted: July 30, 2014)
15
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 2016
Estimated Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Children under 2 years

Exclusion Criteria:

-

Sex/Gender
Sexes Eligible for Study: All
Ages up 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
Responsible Party Raquel Corripio-Collado, Corporacion Parc Tauli
Study Sponsor Corporacion Parc Tauli
Collaborators Not Provided
Investigators Not Provided
PRS Account Corporacion Parc Tauli
Verification Date July 2014