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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

254 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-10

Study Completion Date

2024-10-10

Brief Summary

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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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Detailed Description

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Conditions

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Patent Ductus Arteriosus in Preterm Infants

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Paracetamol Group

Intervention Type DRUG

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

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 Type EXPERIMENTAL

Ibuprofen group

Intervention Type 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.

Interventions

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Paracetamol Group

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

Intervention Type DRUG

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 Type DRUG

Other Intervention Names

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Experimental: Group B: Ibuprofen Group

Eligibility Criteria

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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

Minimum Eligible Age

48 Hours

Maximum Eligible Age

96 Hours

Eligible Sex

ALL

Accepts Healthy Volunteers

No