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NCT01031316 · ClinicalTrials.gov registry record · NA
Patent Ductus Arteriosus (PDA) Screening Trial
A NA study, sponsored by University of Pennsylvania.
- Completed
- Registry status
- NA
- Development phase
- 88
- Enrollment target
NCT01031316: Completed NA study, sponsored by University of Pennsylvania.
NCT01031316 is a NA study that has completed, run by University of Pennsylvania. The registered enrollment target is 88 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01031316, a NA study, has completed, sponsored by University of Pennsylvania.
- COMPLETED
- Registry status
- NA
- Development phase
- 88 participants
- Enrollment target
Study Summary
The ductus arteriosus directs blood away from the pulmonary circulation and toward the systemic circulation during fetal life, then closes after birth. In preterm infants the incidence of spontaneous closure decreases with gestational age. Patent ductus arteriosus (PDA) increases the risks of bronchopulmonary dysplasia (BPD) and necrotizing enterocolitis (NEC). However, this association may not be a causal relationship. Echocardiography is required to diagnose PDA. However, routine screening echocardiograms lead to detection of asymptomatic PDAs, for which the benefit of therapy remains unproven. A randomized controlled trial has been designed in which 88 infants with birth weight less than or equal to 1250 grams and gestational age less than or equal to 30 weeks will be enrolled. The investigators' goal is to determine how screening echocardiography influences clinical management and outcomes in these infants.
Interventions
- OTHER Nondisclosure of screening echocardiogram results
- OTHER Disclosure of screening echocardiogram results
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 88 participants |
| Start Date | 2009-10 |
| Est. Completion | 2011-08 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01031316
The ClinicalTrials.gov registry entry for NCT01031316 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 88 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Pennsylvania, which has 1,423 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Nondisclosure of screening echocardiogram results is the first listed.
NCT01031316 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01031316 about?
NCT01031316 is a clinical study titled "Patent Ductus Arteriosus (PDA) Screening Trial". The ductus arteriosus directs blood away from the pulmonary circulation and toward the systemic circulation during fetal life, then closes after birth. In preterm infants the incidence of spontaneous closure decreases with gestational age. Patent ductus arteriosus (PDA) increases the risks of bronch...
What is the current status of trial NCT01031316?
This trial is currently completed. It is a NA study. The enrollment target is 88 participants. The study started on 2009-10. Estimated completion is 2011-08.
What interventions are being tested in trial NCT01031316?
The interventions under investigation include: Nondisclosure of screening echocardiogram results (OTHER), Disclosure of screening echocardiogram results (OTHER).
Who is sponsoring clinical trial NCT01031316?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
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