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Clinical trialNCT01958320CompletedPhase 2Interventional

Early Treatment Versus Delayed Conservative Treatment of the Patent Ductus Arteriosus

SponsorUniversity of California, San FranciscoEnrollment202Intestinal PerforationNecrotizing EnterocolitisPatent Ductus ArteriosusSurgery
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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".

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

18 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Sweden
  • University Hospital, Umea, Sweden

    Umeå, Sweden

Turkey (Türkiye)
  • Ankara University School of Medicine Children'S Hospital

    Ankara, Turkey (Türkiye)

  • Sisli Hamidiye Etfal Training and Research Hospital

    Istanbul, Turkey (Türkiye)

  • Inonu University School of Medicine Turgut Ozal Medical Center

    Malatya, Turkey (Türkiye)

United Kingdom
  • University of Glasgow, Royal Hospital for Sick Children

    Glasgow, Scotland, United Kingdom

United States
  • Sharp Mary Birch Hospital for Women and Newborns

    San Diego, California, United States

  • University of California San Diego

    San Diego, California, United States

  • University of California San Francisco

    San Francisco, California, United States

  • Mednax Neonatology of San Jose/pediatrix Medical Group

    San Jose, California, United States

  • Kaiser Permanente Santa Clara

    Santa Clara, California, United States

  • South Miami Hospital

    Miami, Florida, United States

  • University of Chicago Medicine

    Chicago, Illinois, United States

  • Northshore University Health System

    Evanston, Illinois, United States

  • Johns Hopkins University

    Baltimore, Maryland, United States

  • Mayo Clinic

    Rochester, Minnesota, United States

  • Morristown Medical Center

    Morristown, New Jersey, United States

  • Columbia University

    New York, New York, United States

  • Providence St Vincent Medical Center

    Portland, Oregon, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

NSAID
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
31 Dec 2013
Primary completion
30 Jun 2017
Completion
30 Jun 2017
Last update posted
30 Nov 2018
Registered enrollment
202
Registry id
NCT01958320

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 4 Nov 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.