Early Check: Expanded Screening in Newborns
Launched by RTI INTERNATIONAL · Aug 29, 2018
Trial Information
Current as of June 26, 2025
Enrolling by invitation
Keywords
ClinConnect Summary
"Background" Newborn screening (NBS) is a state-based public health program that screens babies for a panel of over 30 conditions. It is estimated that about 12,500 newborns each year in the United States are identified with one of the conditions screened in NBS, with each child receiving the benefit of early treatment. For inclusion in newborn screening there must be evidence that pre-symptomatic treatment is more effective than treatment after clinical presentation. Most conditions proposed for newborn screening are rare, however, and researchers have difficulty identifying sufficient num...
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Newborn has newborn screening in North Carolina
- • Newborn lives in North Carolina or South Carolina
- • Newborn is less than 31 days old
- • Person giving consent must have legal custody of the newborn. When the mother retains custody, they must be the person to give consent.
- • Person giving consent must be able to interact with the online permission portal (available in English and Spanish) and give permission online
- Exclusion Criteria:
- • A newborn screening (NBS) sample is unavailable for the newborn
- • Insufficient NBS sample remains to conduct the screening
About Rti International
RTI International is a leading nonprofit research institute dedicated to improving the human condition through innovative scientific research and technical assistance. With a strong focus on health and social science, RTI collaborates with various stakeholders, including government agencies, private organizations, and academic institutions, to advance knowledge and drive impactful solutions. The organization is recognized for its rigorous methodologies and commitment to ethical research practices, making it a trusted sponsor for clinical trials aimed at enhancing public health and advancing medical science. Through its comprehensive approach, RTI International contributes to the development of evidence-based strategies that address pressing health challenges globally.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Research Triangle Park, North Carolina, United States
Patients applied
Trial Officials
Don Bailey, PhD
Principal Investigator
RTI International
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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