The purpose of this study is to determine if adding paracetamol to ibuprofen is superior to ibuprofen only for treatment of patent ductus arteriosus (PDA) in preterm infants.
Randomized control trial to determine if adding paracetamol to ibuprofen is superior to ibuprofen only for treatment of patent ductus arteriosus (PDA) in preterm infants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
24
Ibuprofen 3 doses administered q24h + Paracetamol 12 doses administered q 6h
Ibuprofen 3 doses administered q24h + Placebo : 12 doses administered q 6h
Rambam Medical Center
Haifa, Israel
The incidence of patent ductus arteriosus closure
By echocardiography
Time frame: 3-10 days after first dose of Ibuprofen + study drug
Adverse effects
Renal and liver function, gastrointestinal complications will be assessed from the patient's medical records
Time frame: until discharge home (usually within 2-3 months since recruitment)
The need for surgical ligation for PDA
need for surgical ligation for PDA
Time frame: 3-21 days after first dose of Ibuprofen + study drug
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