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Paracetamol or ibuprofen? A pilot study comparing rescue therapy for PDA in preterm infants within the first month
Arindam Mukherjee1,2, Anupam Gupta1,2, Catherine Fullwood1,2
1The University of Manchester, Manchester, United Kingdom.
Insights
This pilot study found no significant difference in the effectiveness or safety of IV paracetamol versus IV ibuprofen for treating hemodynamically significant patent ductus arteriosus (hsPDA) in preterm infants. Further research is needed to confirm these findings.
Area of Science:
- Neonatal Intensive Care
- Pharmacology
- Clinical Trials
Background:
- Patent ductus arteriosus (PDA) is common in preterm infants.
- Hemodynamically significant PDA (hsPDA) requires effective treatment.
- Current treatments include IV paracetamol and IV ibuprofen.
Purpose of the Study:
- To assess the effectiveness and safety of IV paracetamol compared to IV ibuprofen for rescue treatment of hsPDA in preterm infants.
- To evaluate the study design for a larger trial.
Main Methods:
- Pilot randomized controlled trial in a UK neonatal intensive care unit.
- Recruited preterm infants (<32 weeks gestation or <1500g) with hsPDA.
- Randomized infants to IV paracetamol or IV ibuprofen; assessed primary outcome of hsPDA closure/reduction and secondary outcomes of complications and adverse effects.
Main Results:
- 32 infants recruited; high recruitment (91.4%) and completion (100%) rates.
- Paracetamol group: 37.5% converted to non-hsPDA; Ibuprofen group: 25.0% converted (p=0.704).
- No significant differences in complications (BPD, NEC, IVH, ROP) or adverse effects between groups.
Conclusions:
- The PAIR trial found no difference in efficacy or safety between IV paracetamol and IV ibuprofen for hsPDA rescue treatment.
- The trial demonstrated feasibility for a larger study.
- A larger, definitive study is required to validate these findings.
Aims And Objectives:
To evaluate a study design aimed to assess the effectiveness and safety of IV paracetamol compared to IV ibuprofen for rescue treatment of clinically and hsPDA in preterm infants.
Setting:
This pilot randomised controlled trial was conducted in the regional neonatal intensive care unit in Manchester, UK, between September 2021 and August 2023.
Patients And Methods:
The study recruited preterm infants (gestational age <32 weeks or birth weight <1,500 g) diagnosed with hsPDA via echocardiogram and presenting with signs and symptoms of PDA. Participants were randomised to receive either paracetamol or ibuprofen within the first 28 days of life. The primary outcome was closure or reduction to non-hsPDA, while secondary outcomes included the incidence of short- or medium-term complications of prematurity, such as BPD, NEC, IVH, and ROP. Adverse effects of medications were also reviewed to ensure safety. As part of the pilot design, recruitment, retention and data completeness were evaluated.
Results:
A total of 32 infants were recruited within a 2-year study period. Overall, both groups of infants showed similar baseline characteristics, although ibuprofen group had slightly smaller and sicker infants, despite randomisation. A high proportion of eligible babies were recruited (91.4%) and completed the trial. Post-intervention, 37.5% (16.1-50.0%) of infants in the paracetamol group converted to non-hsPDA, compared to 25.0% (7.3-52.4%) in the ibuprofen group (p = 0.704). There were no statistically significant differences between the two groups in short- or medium-term complications of prematurity or adverse effects. The trial also demonstrated feasibility by achieving the desired sample size in the given time frame with 91% consent and 100% completion.
Conclusions:
The PAIR (Paracetamol and Ibuprofen Research) trial indicated no differences in efficacy or safety between the two treatments. A larger study is required to validate the findings; this trial has demonstrated the feasibility of such a study.
Clinical Trial Registration:
clinicaltrials.gov, identifier NCT04986839.
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