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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1800 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-03-31

Study Completion Date

2011-11-30

Brief Summary

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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

Detailed Description

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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

Conditions

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Severe Combined Immunodeficiency T Cell Lymphocytopenia

Keywords

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TREC T cell Primary Immunodeficiency PID Navajo SCID

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Birth in a study hospital on the Navajo Reservation

Exclusion Criteria

* None

Minimum Eligible Age

1 Day

Maximum Eligible Age

30 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Locations

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Chinle Hospital

Chinle, Arizona, United States

Site Status

Tuba City Hospital

Tuba City, Arizona, United States

Site Status

Countries

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United States

Other Identifiers

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R03HD060311

Identifier Type: NIH

Identifier Source: secondary_id

View Link

H55235-32562-01

Identifier Type: -

Identifier Source: org_study_id