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

NCT06601114 | Active Not Recruiting

• 1 other identifier: 797/DME/KMC
• Study Type: interventional
• Target: 254
• Locations: 1 country
• Sites: 1

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.

Conditions

Patent Ductus Arteriosus in Preterm Infants

Outcome Measures

Primary Outcomes (1)

• Closure of Patent Ductus Arteriosus

  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

  3 days

Study Arms (2)

Group A: Paracetamol Group

ACTIVE COMPARATOR

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

Drug: Paracetamol Group

Group B: Ibuprofen Group

EXPERIMENTAL

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.

Drug: Ibuprofen group

Interventions

Paracetamol Group DRUG

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

Also known as: Experimental: Group B: Ibuprofen Group

Group A: Paracetamol 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.

Group B: Ibuprofen Group

Eligibility Criteria

• Age: 48 Hours - 96 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Arooj Khan: lead

Study Sites (1)

MTI, Khyber Teaching Hospital

Peshawar, Khyber Pakhtunkhwa, 25000, Pakistan

Location

Related Publications (4)

• Ohlsson A, Shah PS. Paracetamol (acetaminophen) for patent ductus arteriosus in preterm or low-birth-weight infants. Cochrane Database Syst Rev. 2015 Mar 11;(3):CD010061. doi: 10.1002/14651858.CD010061.pub2.

  PMID: 25758061 BACKGROUND

• Slaughter JL, Reagan PB, Newman TB, Klebanoff MA. Comparative Effectiveness of Nonsteroidal Anti-inflammatory Drug Treatment vs No Treatment for Patent Ductus Arteriosus in Preterm Infants. JAMA Pediatr. 2017 Mar 6;171(3):e164354. doi: 10.1001/jamapediatrics.2016.4354. Epub 2017 Mar 6.

  PMID: 28046188 BACKGROUND

• Al-Lawama M, Alammori I, Abdelghani T, Badran E. Oral paracetamol versus oral ibuprofen for treatment of patent ductus arteriosus. J Int Med Res. 2018 Feb;46(2):811-818. doi: 10.1177/0300060517722698. Epub 2017 Sep 14.

  PMID: 29239259 BACKGROUND

• Shah SMA, Khan SA, Sadiq F, Gul R, Sadiq F, Khan MU, Khan MK, Uzma F, Khan A, Khan S. Comparison of the Effectiveness of Paracetamol and Ibuprofen in the Management of Patent Ductus Arteriosus in Preterm Neonates: A Randomized Controlled Trial. Mol Cell Pediatr. 2025 Jan 25;12(1):2. doi: 10.1186/s40348-025-00189-x.

  PMID: 39862321 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head Of Paediatrics Sabir Khan

Study Record Dates

• First Submitted: September 2, 2024
• First Posted: September 19, 2024
• Study Start: April 10, 2024
• Primary Completion: October 10, 2024
• Study Completion: October 10, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)