The Effectiveness of Paracetamol Versus Ibuprofen in Management of Patent Ductus Arteriosus in Preterm Neonates
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 254
- Locations
- 1
- Primary Endpoint
- Closure of Patent Ductus Arteriosus
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 48 Hours to 96 Hours (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Group A: Paracetamol Group
Group A: Paracetamol Group will receive Oral form of paracetamol with dosage of 15mg/kg every 6 hours for 3 days
Intervention: Paracetamol Group (Drug)
Group B: 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.
Intervention: Ibuprofen group (Drug)
Outcomes
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
Secondary Outcomes
No secondary outcomes reported
Investigators
Arooj Khan
Head Of Paediatrics Sabir Khan
Khyber Teaching Hospital