The purpose of this study is to determine whether oral paracetamol or ibuprofen has a better or same efficacy and tolerance in closure of patent ductus arteriosus in preterm infants.
To determine whether oral paracetamol or ibuprofen has a better or same efficacy and tolerance in closure of patent ductus arteriosus in preterm infants. Eighty preterm infants with patent ductus arteriosus will be enrolled in this prospective-randomized study. Patients will receive oral ibuprofen at an initial dose of 10 mg/kg, followed by 5 mg/kg at 24 and 48 h or oral paracetamol 15 mg/kg per dose every 6 hours. 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 treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
80
Patients will receive oral paracetamol 15 mg/kg per dose every 6 hours for 3 days.
Patients will receive oral ibuprofen at an initial dose of 10 mg/kg, followed by 5 mg/kg at 24 and 48 h.
Zekai Tahir Burak Maternity Teaching Hospital, Division of Neonatology
Ankara, Turkey (Türkiye)
Efficacy and Safety of Oral Paracetamol Versus Oral Ibuprofen
To compare the closure rate of patent ductus arteriosus after oral paracetamol or oral ibuprofen treatment
Time frame: Until discharge
Long term effects of oral paracetamol versus oral ibuprofen treatment in preterm infants
Long term effects such as ROP, BPD,IVH, duration of respiratory support and hospitalization are going to be evaluated.
Time frame: corrected 36 weeks or until discharge
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