Early Treatment Versus Delayed Conservative Treatment of the Patent Ductus Arteriosus



Status:Completed
Conditions:Colitis, Cardiology, Gastrointestinal
Therapuetic Areas:Cardiology / Vascular Diseases, Gastroenterology
Healthy:No
Age Range:Any
Updated:12/2/2018
Start Date:December 2013
End Date:June 2017

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Early Treatment Versus Delayed Conservative Treatment of the Patent Ductus Arteriosus in Preterm infants-a Multicenter Trial

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".

Prior studies showed that, if a moderate/large Patent Ductus Arteriosus (PDA) is still
present at 5 days after birth (among infants delivered at 23 and 0/7 to 25 and 6/7 weeks
gestation) or at 7 days after birth (among infants delivered at 26 and 0/7 to 27 and 6/7
weeks gestation), it will persist for at least another 4-12 weeks if it is left untreated.

Inclusion Criteria:

This will be a prospective randomized, multi-center, controlled trial that will enroll
infants delivered between 23 & 0/7 - 27 & 6/7 weeks gestation:

1. 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

2. 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

3. are receiving respiratory support consisting of either mechanical ventilation, nasal
CPAP, SiPAP, or nasal cannula flow ≥2 L/min.

Exclusion Criteria:

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.
We found this trial at
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3400 N Charles St
Baltimore, Maryland 21205
410-516-8000
Principal Investigator: Susan Aucott, MD
Johns Hopkins University The Johns Hopkins University opened in 1876, with the inauguration of its...
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116th St and Broadway
New York, New York 10027
(212) 854-1754
Principal Investigator: Richard Polin, MD
Columbia University In 1897, the university moved from Forty-ninth Street and Madison Avenue, where it...
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Chicago, Illinois 60637
Principal Investigator: Jaideep Singh, MD
Phone: 773-702-6210
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Evanston, Illinois 60201
Principal Investigator: Matthew Derrick, MD
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3100 Southwest 62nd Avenue
Miami, Florida 33143
Principal Investigator: Magaly Diaz Barbosa, MD
Phone: 305-205-0177
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Morristown, New Jersey 07962
Principal Investigator: Denise Hassinger, MD
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9205 SW Barnes Rd
Portland, Oregon 97225
(503) 216-1234
Principal Investigator: Joseph Kaempf, MD
Providence St. Vincent Medical Center Providence St. Vincent is renowned for its many centers of...
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Rochester, Minnesota 55905
Principal Investigator: William Carey, MD
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San Diego, California 92123
Principal Investigator: Anup Katheria, MD
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San Diego, California 92093
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San Francisco, California 94143
Principal Investigator: Ronald Clyman, MD
Phone: 415-476-4462
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Santa Clara, California 95051
Principal Investigator: Andrea Wickremasinghe, MD
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Umea,
Principal Investigator: Stellan Håkansson, MD
Phone: +46907850000
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