Surgery Clinical Trial
Official title:
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. ;
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