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Screening for Early Detection and Prevention of Pompe Disease in Israel Using Tandem Mass Spectrometry (LC-MS-MS)

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ClinicalTrials.gov Identifier: NCT01409486
Recruitment Status : Unknown
Verified August 2011 by Rambam Health Care Campus.
Recruitment status was:  Not yet recruiting
First Posted : August 4, 2011
Last Update Posted : August 4, 2011
Sponsor:
Information provided by:

July 7, 2011
August 4, 2011
August 4, 2011
September 2011
September 2013   (Final data collection date for primary outcome measure)
Identification of the normal mean control value of Alpha glucosidase activity in Dry blood spots among Newborns in Israel [ Time Frame: Two years ]
Same as current
No Changes Posted
Not Provided
Not Provided
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Screening for Early Detection and Prevention of Pompe Disease in Israel Using Tandem Mass Spectrometry
Screening for Early Detection and Prevention of Pompe Disease in Israel Using Tandem Mass Spectrometry

The aim of the study is:

to develop a comprehensive biochemical assay for detection of Pompe disease (glycogen storage disease type II), to be implemented in the Newborn screening program among the Israeli population.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
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Non-Probability Sample
10000 full-term newborns born in Northern Israel
Pompe Disease
Other: Drawing blood spots from Newborns
Dry blood spots would be taken for determination of Alpha Glucosidase activity using LC-MS-MS
Not Provided
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
10000
September 2013
September 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • New born babies born during the study period

Exclusion Criteria:

  • Premature babies
Sexes Eligible for Study: All
up to 7 Days   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
Israel
 
 
NCT01409486
0290-09-RMB-CTIL
No
Not Provided
Not Provided
Prof. Hanna Mandel, Rambam Health Care Campus
Rambam Health Care Campus
Not Provided
Not Provided
Rambam Health Care Campus
August 2011