Second Course of Therapy for Resistant Patent Ductus Arteriosus (PDA)
Patency of the ductus arteriosus (PDA) is functionally essential for fetal circulation, however persistence of ductal patency postnatally may have significant adverse hemodynamic effects in the neonate. Medical therapy for PDA predominantly involves the administration of one of two non-steroidal anti-inflammatory drugs: indomethacin or ibuprofen. Both of these therapies have been shown to be successful in mediating ductal closure in approximately 70% of treated infants.
However, the need for a second course of treatment for PDA closure remains quite common. The investigators hypothesize that, because of small differences between the two drugs, a greater percentage of infants who did not respond to a first course of therapy with indomethacin will respond to a second course with ibuprofen than to a repeat course of indomethacin.
As such, the investigators aim to compare secondary therapy with a repeat course of indomethacin to secondary therapy with ibuprofen in infants whose ductus remained patent after a first course of therapy with indomethacin.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Ibuprofen vs. Indomethacin as Second Course of Therapy for Resistant PDA in Low Birth Weight Neonates|
- Improvement in ductal closure rates in those infants who do not respond to a first course of therapy [ Time Frame: 2.5 years ] [ Designated as safety issue: No ]
- More infants who did not respond to a first course of therapy with indomethacin who respond to a second course with ibuprofen than to a repeat course of indomethacin [ Time Frame: 2.5 years ] [ Designated as safety issue: No ]
- Secondary treatment with ibuprofen, as opposed to indomethacin, will not be associated with increased side effects [ Time Frame: 2.5 years ] [ Designated as safety issue: Yes ]
|Study Start Date:||June 2010|
|Estimated Primary Completion Date:||June 2012 (Final data collection date for primary outcome measure)|
Experimental: Indomethacin for resistant PDA
Treatment with second course of indomethacin
Three doses of intravenous (IV) indomethacin at 0.2 mg/kg/dose given over 30 minutes, at intervals of 12 hours
Other Name: Indomed
Experimental: Ibuprofen for resistant PDA
Ibuprofen as second course of therapy
10 mg/kg infused over 30 minutes, followed by two doses of 5mg/kg each at 24 hour intervals
Other Name: Arfen