Status:
RECRUITING
Implementing a Novel Consent Process for Biospecimen Research After Newborn Screening
Lead Sponsor:
Erin Rothwell
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Implementation Science
Informed Consent
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to implement an electronic consent education process for the retention and research use of residual dried bloodspots at four hospitals in Michigan and assess the impact of...
Detailed Description
The research team will compare a prospective observational control group enrolled during pre-implementation data collection within a hospital (n=2,990) to the implemented consent process group enrolle...
Eligibility Criteria
Inclusion
- Adult (\> 18 years)
- English, Spanish or Arabic speaking
- Just gave birth and currently a patient in the Mother \& Baby Unit in the hospital
Exclusion
- Parents of infants who are born pre-term (\< 37 weeks gestation)
- Parents of infants in the Neonatal Intensive Care Unit
- Parents of infants being put up for adoption or in situations where legal guardianship is unknown at the time of birth
Key Trial Info
Start Date :
May 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2028
Estimated Enrollment :
5980 Patients enrolled
Trial Details
Trial ID
NCT06192511
Start Date
May 15 2024
End Date
April 30 2028
Last Update
June 19 2025
Active Locations (2)
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1
University of Utah Hospital and Clinics
Salt Lake City, Utah, United States, 84132
2
University of Utah, Department of Obstetrics & Gynecology
Salt Lake City, Utah, United States, 84132