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NCT03782610 · ClinicalTrials.gov registry record
Early Prediction of Spontaneous Patent Ductus Arteriosus (PDA) Closure and PDA-Associated Outcomes
A clinical trial of Bronchopulmonary Dysplasia and Patent Ductus Arteriosus, sponsored by Nationwide Children's Hospital.
- Active
- Registry status
- 526
- Enrollment target
- 4
- Study locations
NCT03782610 is a study of Bronchopulmonary Dysplasia and Patent Ductus Arteriosus that is active but no longer recruiting, run by Nationwide Children's Hospital. The registered enrollment target is 526 participants, above the 218-participant average among 29 other Bronchopulmonary Dysplasia trials with a reported enrollment target (141% higher). The trial reports 4 study locations across 1 state.
The verdict
NCT03782610, a study of Bronchopulmonary Dysplasia and Patent Ductus Arteriosus, is active but no longer recruiting, sponsored by Nationwide Children's Hospital.
- ACTIVE NOT RECRUITING
- Registry status
- 526 participants
- Enrollment target
- 4
- Study locations
Study 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 long term outcomes including chronic lung disease and neurodevelopmental delay. Although, treatments to close PDA likely benefit some infants, widespread routine treatment of all preterm infants with PDA may not improve important outcomes. Left untreated, most PDAs close spontaneously. Thus, PDA treatment is increasingly controversial and varies markedly between hospitals and individual providers. The relevant and still unanswered clinical question is not whether to treat all preterm infants with PDA, but whom to treat and when. Treatment detriments may outweigh benefits, since all forms of deliberate PDA closure have potential adverse effects, especially in infants destined for early, spontaneous PDA closure. Unfortunately, clinicians cannot currently predict in the 1st month which infants are at highest risk for persistent PDA, and which combination of clinical risk factors, echocardiographic (echo) measurements, and serum biomarkers may best predict PDA-associated harm. The American Academy of Pediatrics has acknowledged early identification of infants at high-risk from PDA as a key research goal for informing future PDA-treatment effectiveness trials. Our objective is to use a prospective cohort of untreated infants with PDA to predict spontaneous ductal closure timing and identify echo measurements and biomarkers that are present in the 1st postnatal month and associated with long-term impairment. Our central hypothesis is that these risk factors can be determined to inform appropriate clinical treatments when necessary. Clinical, serum and urine biomarkers (BNP, NTpBNP, NGAL, H-FABP), and echo variables sequentially collected during each of the first 4 postnatal weeks will be examined. In addition myocardial deformation imaging (MDI) and tissue Doppler imaging (TDI
Conditions Studied
Study Locations (4)
Ohio
- Nationwide Children's Hospital Main Campus Neonatal Intensive Care Unit - Columbus
- Nationwide Children's Neonatal Intensive Care Unit at The Ohio State University Wexner Medical Center - Columbus
- Nationwide Children's Neonatal Intensive Care Unit at OhioHealth Riverside Methodist Hospital - Columbus
- Nationwide Children's Hospital Neonatal Intensive Care Unit at OhioHealth Grant Medical Center - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 526 participants |
| Start Date | 2019-04-01 |
| Est. Completion | 2026-09 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03782610
The ClinicalTrials.gov registry entry for NCT03782610 describes a study currently listed as active not recruiting, categorized as an unspecified phase. The registered enrollment target is 526 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 218-participant average among 29 other Bronchopulmonary Dysplasia trials with a reported enrollment target (141% higher). The listed sponsor is Nationwide Children's Hospital, which has 188 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Bronchopulmonary Dysplasia appearing as the primary indexed condition, and to 0 interventions.
NCT03782610 reports 4 study locations spanning 1 distinct geographic area - top geographies include Ohio.
Frequently Asked Questions
What is clinical trial NCT03782610 about?
NCT03782610 is a clinical study titled "Early Prediction of Spontaneous Patent Ductus Arteriosus (PDA) Closure and PDA-Associated Outcomes". 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 long term outcomes including chronic lung disease and neurodevelopmental delay. Although, treatments t...
What is the current status of trial NCT03782610?
This trial is currently active not recruiting. The enrollment target is 526 participants. The study started on 2019-04-01. Estimated completion is 2026-09.
What conditions does trial NCT03782610 study?
This clinical trial studies the following conditions: Bronchopulmonary Dysplasia, Patent Ductus Arteriosus, Preterm Infant, Neurodevelopmental Abnormality.
Who is sponsoring clinical trial NCT03782610?
This trial is sponsored by Nationwide Children's Hospital, which has 188 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03782610 being conducted?
This trial has 4 study locations across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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