---
title: "Intravenous versus Oral Paracetamol for PDA Closure in Preterm Infants: Randomised Trial Results"
id: "pubmed-42788939"
canonical_url: "https://medichelpline.com/clinical-feed/pubmed-42788939"
content_type: "clinical_feed_article"
specialty: "Critical Care"
source_name: "PubMed / NCBI"
source_url: "https://pubmed.ncbi.nlm.nih.gov/42788939/"
doi: "10.4103/singaporemedj.SMJ-2026-034"
published_at: "2026-09-26T00:00:00.000Z"
evidence_level: "Journal Article"
license: "CC-BY-NC-4.0 / Informational Use"
---
# Intravenous versus Oral Paracetamol for PDA Closure in Preterm Infants: Randomised Trial Results
## Provenance & Clinical Metadata
- **Canonical URL:** https://medichelpline.com/clinical-feed/pubmed-42788939
- **Specialty:** [Critical Care](https://medichelpline.com/clinical-feed/critical-care.md)
- **Primary Source:** PubMed / NCBI
- **Source URL:** [Original Journal Publication](https://pubmed.ncbi.nlm.nih.gov/42788939/)
- **DOI:** [10.4103/singaporemedj.SMJ-2026-034](https://doi.org/10.4103%2Fsingaporemedj.SMJ-2026-034)
- **Published At:** 2026-09-26T00:00:00.000Z
- **Evidence Rating:** Journal Article
## Executive GIST (TL;DR)
- This randomised controlled trial compared **intravenous paracetamol** with **oral paracetamol** for pharmacological closure of haemodynamically significant **patent ductus arteriosus (PDA)** in preterm infants. - Conducted at the neonatal intensive care unit of Hospital Pakar Universiti Sains Malaysia between January 2023 and July 2024. - Fifty preterm infants (gestational age 26+0 to 33+6 weeks) with haemodynamically significant PDA were randomised to receive either oral or intravenous paracetamol at 15 mg/kg every 6 hours for 3 days; a second identical course was permitted if the first failed. - The primary outcome was complete ductal closure; secondary outcomes included changes in ductal size, renal and hepatic function, early complications, and late neonatal morbidities during a 30-day follow-up. - Baseline characteristics were reported as comparable between the two groups. - Ductal closure rates were significantly higher with intravenous paracetamol (92.6%) than with oral paracetamol (69.6%), P = 0.035. - Reduction in ductal size favored intravenous administration (mean reduction 1.81 mm vs 1.34 mm; P = 0.018). - No significant differences were observed between groups for early or late complications; both routes had favorable safety profiles and no serious adverse effects reported. - The trial authors concluded that intravenous paracetamol had superior efficacy for PDA closure in preterm infants while maintaining a similar safety profile to oral paracetamol. - Details such as specific baseline characteristics, exact numbers per arm, breakdown of secondary outcome values, and longer-term outcomes beyond 30 days were not reported in the abstract.
## Clinical Analysis & Structured Key Points
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Online ahead of print. # Efficacy and safety of oral paracetamol versus intravenous paracetamol in preterm infants with patent ductus arteriosus: a randomised controlled trial [Nurshafinaz Salmah Mohd Fezal](https://pubmed.ncbi.nlm.nih.gov/?term=Mohd+Fezal+NS&cauthor_id=42788939)[ 1 ](https://pubmed.ncbi.nlm.nih.gov/42788939/#full-view-affiliation-1 "Department of Paediatrics, School of Medical Sciences, Universiti Sains Malaysia, Malaysia.")[ 2 ](https://pubmed.ncbi.nlm.nih.gov/42788939/#full-view-affiliation-2 "Department of Paediatrics, Hospital Pakar Universiti Sains Malaysia, Health Campus, Malaysia."), [Noraida Ramli](https://pubmed.ncbi.nlm.nih.gov/?term=Ramli+N&cauthor_id=42788939)[ 1 ](https://pubmed.ncbi.nlm.nih.gov/42788939/#full-view-affiliation-1 "Department of Paediatrics, School of Medical Sciences, Universiti Sains Malaysia, Malaysia.")[ 2 ](https://pubmed.ncbi.nlm.nih.gov/42788939/#full-view-affiliation-2 "Department of Paediatrics, Hospital Pakar Universiti Sains Malaysia, Health Campus, Malaysia."), [Nor Rosidah Ibrahim](https://pubmed.ncbi.nlm.nih.gov/?term=Ibrahim+NR&cauthor_id=42788939)[ 1 ](https://pubmed.ncbi.nlm.nih.gov/42788939/#full-view-affiliation-1 "Department of Paediatrics, School of Medical Sciences, Universiti Sains Malaysia, Malaysia.")[ 2 ](https://pubmed.ncbi.nlm.nih.gov/42788939/#full-view-affiliation-2 "Department of Paediatrics, Hospital Pakar Universiti Sains Malaysia, Health Campus, Malaysia."), [Hans Van Rostenberghe](https://pubmed.ncbi.nlm.nih.gov/?term=Van+Rostenberghe+H&cauthor_id=42788939)[ 1 ](https://pubmed.ncbi.nlm.nih.gov/42788939/#full-view-affiliation-1 "Department of Paediatrics, School of Medical Sciences, Universiti Sains Malaysia, Malaysia.")[ 3 ](https://pubmed.ncbi.nlm.nih.gov/42788939/#full-view-affiliation-3 "International Medical School, Management and Science University, Malaysia."), [Mohd Rizal Mohd Zain](https://pubmed.ncbi.nlm.nih.gov/?term=Mohd+Zain+MR&cauthor_id=42788939)[ 1 ](https://pubmed.ncbi.nlm.nih.gov/42788939/#full-view-affiliation-1 "Department of Paediatrics, School of Medical Sciences, Universiti Sains Malaysia, Malaysia.")[ 2 ](https://pubmed.ncbi.nlm.nih.gov/42788939/#full-view-affiliation-2 "Department of Paediatrics, Hospital Pakar Universiti Sains Malaysia, Health Campus, Malaysia."), [Anis Munirah Mohd Kori](https://pubmed.ncbi.nlm.nih.gov/?term=Mohd+Kori+AM&cauthor_id=42788939)[ 1 ](https://pubmed.ncbi.nlm.nih.gov/42788939/#full-view-affiliation-1 "Department of Paediatrics, School of Medical Sciences, Universiti Sains Malaysia, Malaysia.")[ 2 ](https://pubmed.ncbi.nlm.nih.gov/42788939/#full-view-affiliation-2 "Department of Paediatrics, Hospital Pakar Universiti Sains Malaysia, Health Campus, Malaysia.") Affiliations Expand ### Affiliations * 1 Department of Paediatrics, School of Medical Sciences, Universiti Sains Malaysia, Malaysia. * 2 Department of Paediatrics, Hospital Pakar Universiti Sains Malaysia, Health Campus, Malaysia. * 3 International Medical School, Management and Science University, Malaysia. * PMID: **42788939** * DOI: [ 10.4103/singaporemedj.SMJ-2026-034 ](https://doi.org/10.4103/singaporemedj.smj-2026-034) Item in Clipboard # Efficacy and safety of oral paracetamol versus intravenous paracetamol in preterm infants with patent ductus arteriosus: a randomised controlled trial Nurshafinaz Salmah Mohd Fezal et al. Singapore Med J. 2026. Show details Display options Display options Format Abstract PubMed PMID Singapore Med J Actions * [ Search in PubMed ](https://pubmed.ncbi.nlm.nih.gov/?term=%22Singapore+Med+J%22%5Bjour%5D&sort=date&sort_order=desc) * [ Search in NLM Catalog ](https://www.ncbi.nlm.nih.gov/nlmcatalog?term=%22Singapore+Med+J%22%5BTitle+Abbreviation%5D) * [ Add to Search ](https://pubmed.ncbi.nlm.nih.gov/42788939/) . 2026 Sep 26. doi: 10.4103/singaporemedj.SMJ-2026-034. Online ahead of print. ### Authors [Nurshafinaz Salmah Mohd Fezal](https://pubmed.ncbi.nlm.nih.gov/?term=Mohd+Fezal+NS&cauthor_id=42788939)[ 1 ](https://pubmed.ncbi.nlm.nih.gov/42788939/#short-view-affiliation-1 "Department of Paediatrics, School of Medical Sciences, Universiti Sains Malaysia, Malaysia.")[ 2 ](https://pubmed.ncbi.nlm.nih.gov/42788939/#short-view-affiliation-2 "Department of Paediatrics, Hospital Pakar Universiti Sains Malaysia, Health Campus, Malaysia."), [Noraida Ramli](https://pubmed.ncbi.nlm.nih.gov/?term=Ramli+N&cauthor_id=42788939)[ 1 ](https://pubmed.ncbi.nlm.nih.gov/42788939/#short-view-affiliation-1 "Department of Paediatrics, School of Medical Sciences, Universiti Sains Malaysia, Malaysia.")[ 2 ](https://pubmed.ncbi.nlm.nih.gov/42788939/#short-view-affiliation-2 "Department of Paediatrics, Hospital Pakar Universiti Sains Malaysia, Health Campus, Malaysia."), [Nor Rosidah Ibrahim](https://pubmed.ncbi.nlm.nih.gov/?term=Ibrahim+NR&cauthor_id=42788939)[ 1 ](https://pubmed.ncbi.nlm.nih.gov/42788939/#short-view-affiliation-1 "Department of Paediatrics, School of Medical Sciences, Universiti Sains Malaysia, Malaysia.")[ 2 ](https://pubmed.ncbi.nlm.nih.gov/42788939/#short-view-affiliation-2 "Department of Paediatrics, Hospital Pakar Universiti Sains Malaysia, Health Campus, Malaysia."), [Hans Van Rostenberghe](https://pubmed.ncbi.nlm.nih.gov/?term=Van+Rostenberghe+H&cauthor_id=42788939)[ 1 ](https://pubmed.ncbi.nlm.nih.gov/42788939/#short-view-affiliation-1 "Department of Paediatrics, School of Medical Sciences, Universiti Sains Malaysia, Malaysia.")[ 3 ](https://pubmed.ncbi.nlm.nih.gov/42788939/#short-view-affiliation-3 "International Medical School, Management and Science University, Malaysia."), [Mohd Rizal Mohd Zain](https://pubmed.ncbi.nlm.nih.gov/?term=Mohd+Zain+MR&cauthor_id=42788939)[ 1 ](https://pubmed.ncbi.nlm.nih.gov/42788939/#short-view-affiliation-1 "Department of Paediatrics, School of Medical Sciences, Universiti Sains Malaysia, Malaysia.")[ 2 ](https://pubmed.ncbi.nlm.nih.gov/42788939/#short-view-affiliation-2 "Department of Paediatrics, Hospital Pakar Universiti Sains Malaysia, Health Campus, Malaysia."), [Anis Munirah Mohd Kori](https://pubmed.ncbi.nlm.nih.gov/?term=Mohd+Kori+AM&cauthor_id=42788939)[ 1 ](https://pubmed.ncbi.nlm.nih.gov/42788939/#short-view-affiliation-1 "Department of Paediatrics, School of Medical Sciences, Universiti Sains Malaysia, Malaysia.")[ 2 ](https://pubmed.ncbi.nlm.nih.gov/42788939/#short-view-affiliation-2 "Department of Paediatrics, Hospital Pakar Universiti Sains Malaysia, Health Campus, Malaysia.") ### Affiliations * 1 Department of Paediatrics, School of Medical Sciences, Universiti Sains Malaysia, Malaysia. * 2 Department of Paediatrics, Hospital Pakar Universiti Sains Malaysia, Health Campus, Malaysia. * 3 International Medical School, Management and Science University, Malaysia. * PMID: **42788939** * DOI: [ 10.4103/singaporemedj.SMJ-2026-034 ](https://doi.org/10.4103/singaporemedj.smj-2026-034) Item in Clipboard Cite Display options Display options Format Abstract PubMed PMID Linked Discoveries ## Abstract **Introduction:** Despite the widespread use of paracetamol for ductus arteriosus closure in preterm infants, direct comparisons between oral and intravenous paracetamol remain limited. This study aimed to evaluate the efficacy and safety of oral versus intravenous paracetamol for the pharmacological closure of haemodynamically significant patent ductus arteriosus in preterm infants. **Methods:** A randomised controlled trial was conducted at the neonatal intensive care unit of Hospital Pakar Universiti Sains Malaysia from January 2023 to July 2024. Fifty preterm infants (26 weeks to 33 + 6 weeks gestational age) diagnosed with haemodynamically significant patent ductus arteriosus were randomised to receive either oral or intravenous paracetamol (15 mg/kg every 6 h for 3 days). A second course was administered if the initial treatment failed. The primary outcome was complete ductal closure; secondary outcomes included renal and hepatic function, early complications and late neonatal morbidities over a 30-day follow-up period. **Results:** Baseline characteristics were comparable between groups. Ductal closure was significantly higher with intravenous paracetamol than with oral paracetamol (92.6% vs. 69.6%; P = 0.035). The intravenous group also demonstrated greater reduction in ductal size (1.81 mm vs. 1.34 mm; P = 0.018). No significant differences were observed in early or late complications between groups. Both administration routes showed favourable safety profiles without serious adverse effects. **Conclusion:** This study found that intravenous paracetamol had superior efficacy compared with oral administration in achieving ductal closure in preterm infants while maintaining a similar safety profile. **Keywords:** Intravenous paracetamol; neonatal intensive care unit; oral paracetamol; patent ductus arteriosus; preterm infant. Copyright © 2026 Singapore Medical Journal. [PubMed Disclaimer](https://pubmed.ncbi.nlm.nih.gov/disclaimer/) ## References 1. 1. Hammerman C. Patent ductus arteriosus. Clinical relevance of prostaglandins and prostaglandin inhibitors in PDA pathophysiology and treatment. Clin Perinatol 1995;22:457–9. 2. 1. Sancak S, Gokmen Yildirim T, Topcuoglu S, Yavuz T, Karatekin G, Ovali F. Oral versus intravenous paracetamol: Which is better in closure of patent ductus arteriosus in very low birth weight infants?. J Matern Fetal Neonatal Med 2016;29:135–9. 3. 1. Gillam-Krakauer M, Reese J. Diagnosis and management of patent ductus arteriosus. Neoreviews 2018;19:e394–402. 4. 1. Shah SMA, Khan SA, Sadiq F, Gul R, Sadiq F, Khan MU, et al. 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;12:2. 5. 1. Zonnenberg I, de Waal K. The definition of a haemodynamic significant duct in randomized controlled trials: A systematic literature review. Acta Paediatrica 2012;101:247–51. 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