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NCT03655223 · ClinicalTrials.gov registry record
Early Check: Expanded Screening in Newborns
A clinical trial, sponsored by RTI International.
- Active
- Registry status
- 30,000
- Enrollment target
NCT03655223 is a clinical trial that is active but no longer recruiting, run by RTI International. The registered enrollment target is 30,000 participants.
The verdict
NCT03655223 is active but no longer recruiting, sponsored by RTI International.
- ACTIVE NOT RECRUITING
- Registry status
- 30,000 participants
- Enrollment target
Study Summary
Early Check provides voluntary screening of newborns for a selected panel of conditions. The study has three main objectives: 1) develop and implement an approach to identify affected infants, 2) address the impact on infants and families who screen positive, and 3) evaluate the Early Check program. The Early Check screening will lead to earlier identification of newborns with rare health conditions in addition to providing important data on the implementation of this model program. Early diagnosis may result in health and development benefits for the newborns. Infants who have newborn screening in North Carolina will be eligible to participate, equating to over 120,000 eligible infants a year. Over 95% of participants are expected to screen negative. Newborns who screen positive and their parents are invited to additional research activities and services. Parents can enroll eligible newborns on the Early Check electronic Research Portal. Screening tests are conducted on residual blood from existing newborn screening dried blood spots. Confirmatory testing is provided free-of-charge for infants who screen positive, and carrier testing is provided to mothers of infants with fragile X. Affected newborns have a physical and developmental evaluation. Their parents have genetic counseling and are invited to participate in surveys and interviews. Ongoing evaluation of the program includes additional parent interviews.
Interventions
- DIAGNOSTIC_TEST Confirmatory Testing
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30,000 participants |
| Start Date | 2018-10-15 |
| Est. Completion | 2026-12-31 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03655223
The ClinicalTrials.gov registry entry for NCT03655223 describes a study currently listed as active not recruiting, categorized as an unspecified phase. The registered enrollment target is 30,000 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is RTI International, which has 45 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Confirmatory Testing is the first listed.
NCT03655223 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03655223 about?
NCT03655223 is a clinical study titled "Early Check: Expanded Screening in Newborns". Early Check provides voluntary screening of newborns for a selected panel of conditions. The study has three main objectives: 1) develop and implement an approach to identify affected infants, 2) address the impact on infants and families who screen positive, and 3) evaluate the Early Check program....
What is the current status of trial NCT03655223?
This trial is currently active not recruiting. The enrollment target is 30,000 participants. The study started on 2018-10-15. Estimated completion is 2026-12-31.
What interventions are being tested in trial NCT03655223?
The interventions under investigation include: Confirmatory Testing (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT03655223?
This trial is sponsored by RTI International, which has 45 total clinical trials registered on ClinicalTrials.gov.
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