Status:
ACTIVE_NOT_RECRUITING
Early Prediction of Spontaneous Patent Ductus Arteriosus (PDA) Closure and PDA-Associated Outcomes
Lead Sponsor:
Nationwide Children's Hospital
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Ohio State University
Conditions:
Patent Ductus Arteriosus
Preterm Infant
Eligibility:
All Genders
Up to 72 years
Brief Summary
Patent ductus arteriosus (PDA), very common in preterm infants, is the delayed closure of a fetal blood vessel that limits blood flow through the lungs. PDA is associated with mortality and harmful lo...
Eligibility Criteria
Inclusion
- Born between 23-weeks + 0 days (23\_0/7 wks) and 29-weeks + 6 days (29\_6/7 wks) gestation, inclusive
- Admitted to a study neonatal intensive care unit (NICU) within 72-hours of birth
- PDA noted on initial screening echo at \<72 postnatal hours
Exclusion
- Life-threatening congenital abnormalities, including congenital heart disease (other than PDA or small atrial septal defects/patent foramen ovale/muscular VSD)
- Parents have chosen to allow natural death (placed a do not resuscitate order)
Key Trial Info
Start Date :
April 1 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
675 Patients enrolled
Trial Details
Trial ID
NCT03782610
Start Date
April 1 2019
End Date
June 1 2026
Last Update
March 28 2025
Active Locations (4)
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1
Nationwide Children's Hospital Main Campus Neonatal Intensive Care Unit
Columbus, Ohio, United States, 43205
2
Nationwide Children's Neonatal Intensive Care Unit at The Ohio State University Wexner Medical Center
Columbus, Ohio, United States, 43210
3
Nationwide Children's Neonatal Intensive Care Unit at OhioHealth Riverside Methodist Hospital
Columbus, Ohio, United States, 43214
4
Nationwide Children's Hospital Neonatal Intensive Care Unit at OhioHealth Grant Medical Center
Columbus, Ohio, United States, 43215