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

Not Applicable

Active, not recruiting

• Conditions: Patent Ductus Arteriosus in Preterm Infants
• Interventions: Drug: Paracetamol Group; Drug: Ibuprofen group

• Registration Number: NCT06601114
• Lead Sponsor: Arooj Khan

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-10
• Status Verified: 2024-09
• Study First Submitted: 2024-09-02
• Study First Submitted QC: 2024-09-15
• Last Update Submitted: 2024-09-15
• Study First Posted: 2024-09-19
• Last Update Posted: 2024-09-19
• Primary Completion: 2024-10-10
• Study Completion: 2024-10-10

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 254

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Closure of Patent Ductus Arteriosus	3 days	The primary outcome is defined as the number of participants who achieve complete closure of the patent ductus arteriosus (PDA) after a course of the drug, as confirmed by echocardiography. Complete closure will be determined by the absence of ductal flow on color Doppler echocardiography

Trial Locations

Locations (1)

MTI, Khyber Teaching Hospital; 🇵🇰 Peshawar, Khyber Pakhtunkhwa, Pakistan