NCT01958320

Early Treatment Versus Delayed Conservative Treatment of the Patent Ductus Arteriosus

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 202 (actual)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 5 Days – 14 Days
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Patent Ductus Arteriosus
• Surgery
• Necrotizing Enterocolitis
• Intestinal Perforation

Interventions

Type	Name	Description
OTHER	pharmacologic treatment of the PDA	Following randomization, infants will be treated with medications used to produce PDA closure.
OTHER	no pharmacologic treatment of the PDA	Following randomization, infants will NOT be treated with medications used to produce PDA closure (unless they develop rescue criteria at a later point in time).
DRUG	NSAID	Indomethacin, ibuprofen or acetaminophen will be used as standard of care treatment

Timeline

• Start date: 2013-12-01
• Primary completion: 2017-06-01
• Completion: 2017-06-01
• First posted: 2013-10-09
• Last updated: 2018-11-30
• Results posted: 2018-11-30

Locations

18 sites across 4 countries: United States, Sweden, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study