Diabetes Mellitus Clinical Trial
Official title:
Early Check: A Collaborative Innovation to Facilitate Pre-Symptomatic Clinical Trials in Newborns
Verified date | March 2024 |
Source | RTI International |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Enrolling by invitation |
Enrollment | 30000 |
Est. completion date | December 31, 2025 |
Est. primary completion date | November 30, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 1 Day to 31 Days |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | RTI International | Research Triangle Park | North Carolina |
Lead Sponsor | Collaborator |
---|---|
RTI International | Asuragen, Inc., Cure SMA, Duke University, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), GeneDx, Illumina, Inc., Janssen Pharmaceuticals, Juvenile Diabetes Research Foundation, Muscular Dystrophy Association, National Center for Advancing Translational Sciences (NCATS), North Carolina Department of Health and Human Services, Sarepta Therapeutics, Inc., The John Merck Fund, The Leona M. and Harry B. Helmsley Charitable Trust, The National Fragile X Foundation, University of North Carolina, Chapel Hill, Wake Forest University |
United States,
Bailey, Raspa, Bishop & Holiday, 2009
Birnkrant, et al, 2018
Finkel, Mercuri, Darras, Kuntz, Kirschner et al, 2017
Winarni, Schneider, Borodyanskara, & Hagerman, 2012
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence Rates: Number of newborns who screen positive comparative to the whole sample | Incidence rates of infants who screen positive for conditions on the Early Check panel. | Every 6 months for approximately three years | |
Secondary | Impact of Screening: Semi-structured parent interviews. | Each project year, we will recruit mothers whose newborns screen negative and mothers whose newborns screen positive to participate in an approximately 30-minute, semi-structured telephone interview about their perceptions of Early Check and the impact of screening results. | Measured within 6 months of participant screening results |
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