Dec. 16, 2014
Below are current clinical trials.1 studies in Patent ductus arteriosus (PDA)
(open studies only).
Filter this list of studies by location, status and more.
Early Treatment Versus Delayed Conservative Treatment of the Patent Ductus Arteriosus
Study type: Interventional What is this?
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study phase: II What is this?
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.
About this study
The primary goal of the trial is to compare two different Patent Ductus Arteriosus (PDA) treatment approaches: 1) an "early treatment" approach or 2) a "conservative" approach. For the purposes of the study infants will be enrolled if they are delivered before 28 weeks gestation and have a moderate/large PDA present at 5-7 days after birth.
The hypothesis is: treatment of a moderate size patent ductus arteriosus (PDA) will decrease the time needed for assisted respiratory support, diuretic therapy, and gavage feeding assistance, in addition to decreasing the incidence of ductus ligations or need for future outpatient cardiology follow-up appointments. The investigators hypothesize that one or more of these benefits will occur without an increase in the time taken to achieve full enteral feedings or in the incidence of necrotizing enterocolitis (NEC) or spontaneous intestinal perforations (SIP).The investigators will be comparing the effectiveness of early pharmacologic treatment with a control group of conservatively managed infants who will only receive treatment if they meet specific criteria for "rescue treatment".
Participating Mayo Clinic locations
Study statuses change often. Please contact us for help.
Print study details
- Rochester, Minnesota: 13-001922
NCT ID: NCT01958320
Sponsor Protocol Number: RC4
- What is patent ductus arteriosus? National Heart, Lung, and Blood Institute. http://www.nhlbi.nih.gov/health/health-topics/topics/pda/. Accessed Oct. 20, 2014.
- Patent ductus arteriosus. The Merck Manual Professional Edition. http://www.merckmanuals.com/professional/pediatrics/congenital_cardiovascular_anomalies/patent_ductus_arteriosus_pda.html?qt=patent%20ductus%20arteriosus&alt=sh. Accessed Oct. 20, 2014.
- Doyle T, et al. Clinical manifestations and diagnosis of patent ductus arteriosus. http://www.uptodate.com/home. Accessed Oct. 20, 2014.
- Doyle T, et al. Management of patent ductus arteriosus. http://www.uptodate.com/home. Accessed Oct. 20, 2014.
- Planning for pregnancy. Centers for Disease Control and Prevention. http://www.cdc.gov/preconception/planning.html. Accessed Oct. 22, 2014.
- Riggin EA. Decision Support System. Mayo Clinic, Rochester, Minn. July 10, 2014.