Early Treatment Versus Delayed Conservative Treatment of the Patent Ductus Arteriosus
Public ClinicalTrials.gov record NCT01958320. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Early Treatment Versus Delayed Conservative Treatment of the Patent Ductus Arteriosus in Preterm infants-a Multicenter Trial
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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".
Study identification
- NCT ID
- NCT01958320
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 202 participants
Conditions and interventions
Interventions
- pharmacologic treatment of the PDA Other
- no pharmacologic treatment of the PDA Other
- NSAID Drug
Other · Drug
Eligibility (public fields only)
- Age range
- 5 Days to 14 Days
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 2013 (Type not available)
- Primary completion
- Jun 2017 (Actual)
- Completion
- Jun 2017 (Actual)
- Last update posted
- Nov 30, 2018
2013 – 2017
United States locations
- U.S. sites
- 13
- U.S. states
- 8
- U.S. cities
- 12
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of California San Diego | San Diego | California | 92093-0934 | — |
| Sharp Mary Birch Hospital for Women and Newborns | San Diego | California | 92123 | — |
| University of California San Francisco | San Francisco | California | 94143 | — |
| Mednax Neonatology of San Jose/Pediatrix Medical Group | San Jose | California | 92868 | — |
| Kaiser Permanente Santa Clara | Santa Clara | California | 95051 | — |
| South Miami Hospital | Miami | Florida | 33143 | — |
| University of Chicago Medicine | Chicago | Illinois | 60637 | — |
| Northshore University Health System | Evanston | Illinois | 60201 | — |
| Johns Hopkins University | Baltimore | Maryland | 21218 | — |
| Mayo Clinic | Rochester | Minnesota | 55902 | — |
| Morristown Medical Center | Morristown | New Jersey | 07960 | — |
| Columbia University | New York | New York | 10032 | — |
| Providence St Vincent Medical Center | Portland | Oregon | 97225 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 5 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01958320, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 30, 2018 · Synced Oct 20, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01958320 live on ClinicalTrials.gov.