Clinical Trial: Early Treatment Versus Delayed Conservative Treatment of the Patent Ductus Arteriosus
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Early Treatment Versus Delayed Conservative Treatment of the Patent Ductus Arteriosus in Preterm infants-a Multicenter Trial
Brief Summary:
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".
Detailed Summary: 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.
Sponsor: University of California, San Francisco
Current Primary Outcome: The primary outcome will be the number of infants who undergo in hospital PDA ligations or who have an open ductus at the time of discharge (that need future outpatient cardiology follow-up visits) [ Time Frame: up to 12 months after hospital discharge ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- duration of different types of respiratory support (ventilation, CPAP, cannula) [ Time Frame: up to 20 weeks of age ]
- duration of gavage feeding assistance [ Time Frame: up to 20 weeks of age ]
- incidence of necrotizing enterocolitis or spontaneous perforation [ Time Frame: up to 20 weeks of age ]
Original Secondary Outcome: Same as current
Information By: University of California, San Francisco
Dates:
Date Received: October 4, 2013
Date Started: December 2013
Date Completion: December 2018
Last Updated: October 26, 2016
Last Verified: October 2016
