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This study aims to find and compare the effectiveness of paracetamol and ibuprofen in the closure of patent ductus arteriosus in preterm neonates. The study is being conducted at Department of Nursery (special care baby unit) and Neonatal intensive care unit (NICU), KTH, Peshawar. Neonates diagnosed with patent ductus arteriosus (PDA) in the Special care baby unit (SCBU) and Neonatal Intensive Care Unit (NICU) were enrolled in the study after obtaining ethical approval and informed consent from caretakers. The babies received routine care according to departmental policies. For PDA management, participants were randomly assigned to Group A, receiving oral paracetamol (Panadol, 15 mg/kg every 6 hours for 3 days), or Group B, receiving oral ibuprofen (Brufen, 10 mg/kg followed by 5 mg/kg after 24 and 48 hours). Paracetamol was defined as a selective COX-2 inhibitor, while ibuprofen was a non-selective COX inhibitor, both working by inhibiting prostaglandin synthesis. Procedures were supervised by a consultant pediatrician, with continuous patient monitoring. Treatment effectiveness, defined as complete PDA closure on echocardiography, was assessed at the end of the study.
Age
0 - 0 years
Sex
ALL
Healthy Volunteers
No
MTI, Khyber Teaching Hospital
Peshawar, Khyber Pakhtunkhwa, Pakistan
Start Date
April 10, 2024
Primary Completion Date
October 10, 2024
Completion Date
October 10, 2024
Last Updated
September 19, 2024
254
ESTIMATED participants
Paracetamol Group
DRUG
Ibuprofen group
DRUG
Lead Sponsor
Arooj Khan
Data Source & Attribution
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