Newborn Screening for Severe Combined Immunodeficiency (SCID) in a High-Risk Population

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00845416
First received: February 17, 2009
Last updated: July 13, 2012
Last verified: July 2012

February 17, 2009
July 13, 2012
March 2009
November 2011   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00845416 on ClinicalTrials.gov Archive Site
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Newborn Screening for Severe Combined Immunodeficiency (SCID) in a High-Risk Population
Newborn Screening for SCID in a High-Risk Population

The goal of the proposed research is to establish the validity of a newborn screening method for severe combined immunodeficiency (SCID). The assay to be used is developed on the basis of PCR quantification of T-cell receptor excision circles (TRECs) that is absent in SCID patients, thus correlating with the disease

To show that early diagnosis of SCID with a TREC screening assay can warrant timely treatment of the disease and avoid life-threatening infections on patients. Babies with SCID are unable to fight infections. They become severely ill in their first months of life and do not survive unless their immune systems can be restored. SCID can be treated by bone marrow transplant if recognized early. The newborn screening test to be employed in this study is designed to diagnose SCID before infections occur. By conducting a pilot testing program in a high-risk population on the Navajo Indian Reservation, where one in 2,000 infants is born with SCID, we hope to confirm the benefits of newborn screening for early diagnosis of SCID

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Navajo Indians

  • Severe Combined Immunodeficiency
  • T Cell Lymphocytopenia
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1800
November 2011
November 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Birth in a study hospital on the Navajo Reservation

Exclusion Criteria:

  • None
Both
up to 30 Days
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00845416
H55235-32562-01, R03HD060311
No
University of California, San Francisco
University of California, San Francisco
Not Provided
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University of California, San Francisco
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP