An interventional study of oral ibuprofen in Patent Ductus Arteriosus, sponsored by Zekai Tahir Burak Women's Health Research and Education Hospital. Completed at 1 site in Turkey. Open to participants aged 1 Day to 7 Days. Per ClinicalTrials.gov, last updated 2011-08-09.
Sponsored by Zekai Tahir Burak Women's Health Research and Education Hospital · Not applicable, Interventional, and Treatment
To determine whether oral or intravenous ibuprofen has a better or same efficacy and tolerance in closure of patent ductus arteriosis in extremely-low-birth-weight preterm infants.
To determine whether oral or intravenous ibuprofen has a better or same efficacy and tolerance in closure of patent ductus arteriosis in extremely-low-birth-weight preterm infants.Seventy ELBW preterm infants with patent ductus arteriosis will be enrolled in this prospective-randomized study. Patients will receive either intravenous or oral ibuprofen at an initial dose of 10 mg/kg, followed by 5 mg/kg at 24 and 48 h.
One of the following echocardiographic criteria of a duct size >1.5 mm, a left atrium-to-aorta ratio >1.5, left-to-right shunting of blood, end diastolic reversal of blood flow in the aorta, or poor cardiac function in addition signs of patent ductus arteriosis determined the need of ibuprofen treatment.
144 studies on the registry are indexed under Ductus Arteriosus, Patent; 17 are open to participants now.
This study's planned enrollment of 70 is below the median of 80 across 81 interventional studies indexed under Ductus Arteriosus, Patent.
Browse Ductus Arteriosus, Patent studies →Zekai Tahir Burak Women's Health Research and Education Hospital is the lead sponsor of 62 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Extremely low birth weight patients receiving iv ibuprofen
Drug: oral ibuprofen
Extremely low birth weight patients receiving oral ibuprofen
Drug: oral ibuprofen
oral or iv ibuprofen in 10, 5 and 5 mg/kg/day with 24 hr intervals
Efficacy and Safety of Oral Versus Intravenous Ibuprofen... ID: STO5336205575
To compare the closure rate of patent ductus arteriosus after intravenous or oral ibuprofen treatment
Time frame: 6 months
Efficacy and Safety of Oral Versus Intravenous Ibuprofen
Evaluation of renal tolerance and complications
Time frame: Results will be identified in 6 months
This study is completed, as verified in Nov 2010. You cannot join it, but the record below documents what was studied.
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Zekai Tahir Burak Women's Health Research and Education Hospital