Early Treatment Versus Delayed Conservative Treatment of the Patent Ductus Arteriosus

PHASE2CompletedINTERVENTIONAL
Enrollment

202

Participants

Timeline

Start Date

December 31, 2013

Primary Completion Date

June 30, 2017

Study Completion Date

June 30, 2017

Conditions
Patent Ductus ArteriosusSurgeryNecrotizing EnterocolitisIntestinal Perforation
Interventions
OTHER

pharmacologic treatment of the PDA

Following randomization, infants will be treated with medications used to produce PDA closure.

OTHER

no pharmacologic treatment of the PDA

Following randomization, infants will NOT be treated with medications used to produce PDA closure (unless they develop rescue criteria at a later point in time).

DRUG

NSAID

Indomethacin, ibuprofen or acetaminophen will be used as standard of care treatment

Trial Locations (18)

10032

Columbia University, New York

21218

Johns Hopkins University, Baltimore

33143

South Miami Hospital, Miami

55902

Mayo Clinic, Rochester

60201

Northshore University Health System, Evanston

60637

University of Chicago Medicine, Chicago

92123

Sharp Mary Birch Hospital for Women and Newborns, San Diego

92868

Mednax Neonatology of San Jose/Pediatrix Medical Group, San Jose

94143

University of California San Francisco, San Francisco

95051

Kaiser Permanente Santa Clara, Santa Clara

97225

Providence St Vincent Medical Center, Portland

92093-0934

University of California San Diego, San Diego

07960

Morristown Medical Center, Morristown

Unknown

University Hospital, Umea, Sweden, Umeå

Ankara University School of Medicine Children's Hospital, Ankara

Sisli Hamidiye Etfal Training and Research Hospital, Istanbul

Inonu University School of Medicine Turgut Ozal Medical Center, Malatya

G38SJ

University of Glasgow, Royal Hospital for Sick Children, Glasgow

All Listed Sponsors
lead

University of California, San Francisco

OTHER

NCT01958320 - Early Treatment Versus Delayed Conservative Treatment of the Patent Ductus Arteriosus | Biotech Hunter | Biotech Hunter