Early Treatment Versus Delayed Conservative Treatment of the Patent Ductus Arteriosus

Completed · Phase 2

Conditions studied: Patent Ductus Arteriosus, Surgery, Necrotizing Enterocolitis, Intestinal Perforation

In brief

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".

Key facts

Study ID

NCT01958320

Run by

University of California, San Francisco

People needed

202

Starts

2013-12-01

Expected to finish

2017-06-01

Last updated by the study team

2018-11-30

Who can join

Age: 0 and older, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• This will be a prospective randomized, multi-center, controlled trial that will enroll infants delivered between 23 \& 0/7 - 27 \& 6/7 weeks gestation:
• infants must be between 5-14 days old (if delivered between 23 and 0/7 - 25 and 6/7 weeks) or 7-14 days old (if delivered between 26 \& 0/7 - 27 \& 6/7 weeks) and
• have a "moderate size PDA" (defined as a PDA on echocardiogram that has at least one of the following criteria: internal ductus diameter ≥1.5 mm/kg (or PDA:LPA ratio ≥0.5), ductus flow velocity ≤2.5 m/s or mean pressure gradient across the ductus <8 mm, LA/Ao ratio ≥1.5, left pulmonary artery diastolic (or mean) flow velocity >0.2 (or >0.42) m/sec, respectively, and/or reversed diastolic flow in the descending aorta)(13, 68, 69) and
• are receiving respiratory support consisting of either mechanical ventilation, nasal CPAP, SiPAP, or nasal cannula flow ≥2 L/min.

You may not qualify if…

• prior treatment with indomethacin, ibuprofen, or acetaminophen, contraindications for the use of indomethacin, ibuprofen, or acetaminophen (these include: hydrocortisone administration within 24 hrs, urine output < 1 ml/kg/h during the preceding 8 h, serum creatinine level >1.6 mg/dl, platelet count <50, 000/mm3, abnormal coagulation studies, or total bilirubin concentration (in mg/dL) > 8 x weight (in kg)), chromosomal anomalies, congenital or acquired gastrointestinal anomalies, prior episode of necrotizing enterocolitis or intestinal perforation.

Where it is running

• University of California San Diego — San Diego, California, United States
• Sharp Mary Birch Hospital for Women and Newborns — 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
• University Hospital, Umea, Sweden — Umeå, Sweden
• 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)
• University of Glasgow, Royal Hospital for Sick Children — Glasgow, Scotland, United Kingdom

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.