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

Arooj Khan

Status: Active, not recruiting

Conditions: Patent Ductus Arteriosus in Preterm Infants

Treatments: Drug: Ibuprofen group; Drug: Paracetamol Group

Study type: Interventional

Funder types: Other

Identifiers

NCT06601114

797/DME/KMC

Details and patient eligibility

About

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.

Enrollment: 254 estimated patients

Sex: All

Ages: 48 to 96 hours old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Neonates of gestational age more than 30 weeks and less than 37 weeks
• Neonates with birthweight of ≥1250g
• Neonates with postnatal age of 48-96 hours
• Neonates having one of the following echocardiographic criteria: a duct size > 2mm, a left atrium-to-aorta ratio >1.4, end diastolic reversal of blood flow in the aorta, or poor cardiac function in addition to clinical signs of patent ductus arteriosus

Exclusion criteria

• Gestational age less than 30 weeks and more than 37 weeks
• Presence of major congenital abnormalities
• Right-to-left ductal shunting
• Life-threatening infection
• Grade III or grade IV intraventricular hemorrhage
• Platelet count of <60000/mm3
• Hyperbilirubinemia requiring blood transfusion
• Persistent pulmonary hypertension

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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254 participants in 2 patient groups

Group A: Paracetamol Group

Active Comparator group

Description:

Group A: Paracetamol Group will receive Oral form of paracetamol with dosage of 15mg/kg every 6 hours for 3 days

Treatment:

Drug: Paracetamol Group

Group B: Ibuprofen Group

Experimental group

Description:

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.

Treatment:

Drug: Ibuprofen group