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

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.

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Key information

Conditions

Patent Ductus Arteriosus in Preterm Infants

Age range

48 hour–96 hour

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

MTI, Khyber Teaching Hospital

Peshawar, Khyber Pakhtunkhwa, 25000, Pakistan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Paracetamol Group

Drug

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

Other names: Experimental: Group B: Ibuprofen Group

Ibuprofen group

Drug

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 outcomes

Closure of Patent Ductus Arteriosus

Time frame: 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

Sponsors and collaborators

Lead sponsor

Arooj Khan

Other

Registry information

Important dates

Study start: 2024
Primary completion: 2024
Study completion: 2024
First posted: Sep 19, 2024
Registry last updated: Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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