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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paracetamol Group | Drug | Group A: Paracetamol Group will receive Oral form of paracetamol with dosage of 15mg/kg every 6 hours for 3 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MTI, Khyber Teaching Hospital | Peshawar | Khyber Pakhtunkhwa | 25000 | Pakistan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25758061 | Background | 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. | |
| 28046188 | 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. |
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|
| 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. |
|
| 29239259 | 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. |
| 39862321 | Derived | 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. |