NCT03655223Active, not recruiting
Early Check: Expanded Screening in Newborns
Early Check: A Collaborative Innovation to Facilitate Pre-Symptomatic Clinical Trials in Newborns
Source: ClinicalTrials.gov · Last updated 1 Jul 2026
Brief summary (registry, in English)
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 (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 30000 (estimated)
- First submitted
- 16 Aug 2018
- Start date
- 15 Oct 2018
- Primary completion date
- 30 Nov 2026
- Lead sponsor
- RTI International
- Diseases
- Epilepsy, Frontotemporal dementia, Spinal muscular atrophy, Haemophilia, Cystic fibrosis, Duchenne muscular dystrophy, Sickle cell disease, Thalassaemia, Type 1 diabetes, Childhood cancers, Type 2 diabetes
- NCT number
- NCT03655223
What you commit to
- Study type: Observational
- Planned participants: 30000
- From 15 Oct 2018 to the primary completion date, 30 Nov 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- A newborn screening (NBS) sample is unavailable for the newborn
- Insufficient NBS sample remains to conduct the screening
Who the study is looking for
- 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
Age in the registry: 1 day to 31 days · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| RTI International Coordinator of this site? Confirm its status | Research Triangle Park | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.