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Growth Hormone in Children Under 2 Years With Prader-Willi in 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 : Completed
First Posted : July 31, 2014
Last Update Posted : March 31, 2022
Sponsor:
Information provided by (Responsible Party):
Raquel Corripio-Collado, Corporacion Parc Tauli

Study Description
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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.


Condition or disease Intervention/treatment
Prader-Willi Syndrome Drug: Recombinant Somatropin

Study Design
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Study Type : Observational
Actual Enrollment : 16 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Study Start Date : September 2014
Actual Primary Completion Date : July 29, 2019
Actual Study Completion Date : July 29, 2019

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Children under 2 years with Prader-Willi Syndrome Drug: Recombinant Somatropin


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Evaluate the impact of treatment with GH in kids under 2 years old on body composition [ Time Frame: Every 3 months during 2 years ]
  2. Evaluate the impact of treatment with GH in kids under 2 years old on start walking [ Time Frame: Every 3 months during 2 years ]
  3. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   3 Months to 2 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Hospitalary population
Criteria

Inclusion Criteria:

  • Children under 2 years

Exclusion Criteria:

-

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02205450


Locations
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Spain
Corporació Sanitària Parc Taulí
Sabadell, Barcelona, Spain, 08208
Sponsors and Collaborators
Corporacion Parc Tauli
Investigators
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Principal Investigator: Raquel Corripio, PI Corporacio PT
More Information
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Additional Information:

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Responsible Party: Raquel Corripio-Collado, MD PhD, Corporacion Parc Tauli
ClinicalTrials.gov Identifier: NCT02205450    
Other Study ID Numbers: CPT_ENDOPED201401
First Posted: July 31, 2014    Key Record Dates
Last Update Posted: March 31, 2022
Last Verified: March 2022
Keywords provided by Raquel Corripio-Collado, Corporacion Parc Tauli:
Prader-Willi Syndrome
Growth Hormone
Children
Additional relevant MeSH terms:
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Prader-Willi Syndrome
Syndrome
Disease
Pathologic Processes
Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
 Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn
Obesity
Overnutrition
Nutrition Disorders