Patent Ductus Arteriosus Clinical Trial
Official title:
Ibuprofen vs. Indomethacin as Second Course of Therapy for Resistant PDA in Low Birth Weight Neonates
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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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