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Trial record 21 of 111 for:    Pompe Disease

Feasability and Interest of Screening for Infantile Pompe's Diseases at Birth (DEPIPOMP1)

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: NCT02904395
Recruitment Status : Completed
First Posted : September 19, 2016
Last Update Posted : September 19, 2016
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier de Cayenne

Tracking Information
First Submitted Date September 6, 2016
First Posted Date September 19, 2016
Last Update Posted Date September 19, 2016
Study Start Date April 2014
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 13, 2016)
  • acid maltase activity [ Time Frame: At birth ]
    The acid maltase enzyme activity is evaluated just after birth. If it is abnormal then PCR allows to identify signature mutations.
  • Signature mutation for pompe's disease [ Time Frame: At birth ]
    The acid maltase enzyme activity is evaluated just after birth. If it is abnormal then PCR allows to identify signature mutations.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Feasability and Interest of Screening for Infantile Pompe's Diseases at Birth
Official Title Feasability and Interest of Screening for Infantile Pompe's Diseases at Birth
Brief Summary Given the 100 fold increase of the incidence of Pompe's disease in Western French Guiana, the objective of the present study is to implement systematic screening in newborns in French Guiana in order to start treatment before the muscular and cardiac symptoms appear.
Detailed Description Not Provided
Study Type Observational
Study Design Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
filter paper with blood to look for enzyme activity and if enzyme activity low, PCR looking for the signature mutations for infantile Pompe's Disease
Sampling Method Non-Probability Sample
Study Population newborns
Condition Pompe's Disease
Intervention Other: observational (no intervention)
Study Groups/Cohorts Not Provided
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 Completed
Actual Enrollment
 (submitted: September 13, 2016)
3413
Original Actual Enrollment Same as current
Actual Study Completion Date August 2015
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • newborn

Exclusion Criteria:

  • parent refusal
Sex/Gender
Sexes Eligible for Study: All
Ages up to 2 Days   (Child)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT02904395
Other Study ID Numbers DEPIPOMP1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Centre Hospitalier de Cayenne
Study Sponsor Centre Hospitalier de Cayenne
Collaborators Not Provided
Investigators Not Provided
PRS Account Centre Hospitalier de Cayenne
Verification Date September 2016