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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.
Age
0 - 0 years
Sex
ALL
Healthy Volunteers
No
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
Start Date
December 1, 2013
Primary Completion Date
June 1, 2017
Completion Date
June 1, 2017
Last Updated
November 30, 2018
202
ACTUAL participants
pharmacologic treatment of the PDA
OTHER
no pharmacologic treatment of the PDA
OTHER
NSAID
DRUG
Lead Sponsor
University of California, San Francisco
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT04246463