NCT06601114

The Effectiveness of Paracetamol Versus Ibuprofen in Management of Patent Ductus Arteriosus in Preterm Neonates

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 254 (estimated)
• Sponsor: Arooj Khan · Academic / Other
• Sex: All
• Age: 48 Hours – 96 Hours
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Patent Ductus Arteriosus in Preterm Infants

Interventions

Type	Name	Description
DRUG	Paracetamol Group	Group A: Paracetamol Group will receive Oral form of paracetamol with dosage of 15mg/kg every 6 hours for 3 days
DRUG	Ibuprofen group	Group B: Ibuprofen Group will receive oral form of ibuprofen at initial dosage of 10mg/kg followed by 5mg/kg after 24 hours and 48 hours.

Timeline

• Start date: 2024-04-10
• Primary completion: 2024-10-10
• Completion: 2024-10-10
• First posted: 2024-09-19
• Last updated: 2024-09-19

Locations

1 site across 1 country: Pakistan