Intravenous paracetamol vs. ibuprofen for hsPDA in preterm infants

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Created On: 24/04/2026

The PAIR (Paracetamol and Ibuprofen Research) trial sought to determine the effectiveness and safety of intravenous (IV) paracetamol vs IV ibuprofen as rescue therapy for patent ductus arteriosus (hsPDA) in preterm neonates.

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Key take away

Both IV paracetamol and IV ibuprofen exhibit similar efficacy and safety in achieving hemodynamically significant patent ductus arteriosus closure in preterm infants, with no significant difference in neonatal outcomes.

Background

Method

This pilot randomized controlled trial (RCT) was performed in a regional neonatal intensive care unit (NICU). Preterm neonates with gestational age <32 weeks or birth weight <1,500 g, diagnosed with hsPDA confirmed by echocardiography and exhibiting clinical symptoms, were recruited. They were randomly assigned to get either IV paracetamol or IV ibuprofen during the first 28 days of life.

The primary outcome ascertained was ductal closure or reduction to non-hemodynamically significant PDA. Secondary endpoints included prematurity-related complications, such as:

Bronchopulmonary dysplasia (Chronic lung disease due to prolonged oxygen therapy and mechanical ventilation)
Necrotizing enterocolitis (Severe intestinal inflammation leading to necrosis)
Intraventricular hemorrhage (Bleeding into the brain ventricles)
Retinopathy of prematurity (Abnormal retinal blood vessel development)

Additionally, drug safety profiles, along with recruitment rate, retention, and data completeness, were analyzed to determine trial feasibility.

Result

Overall, 32 preterm infants were enrolled over a two-year period. Baseline characteristics were broadly comparable between groups, although infants in the ibuprofen arm were slightly smaller and clinically more unstable despite randomization. The trial achieved a high recruitment rate (91.4%) with 100% study completion, supporting feasibility. Following treatment:

37.5% (16.1–50.0%) of infants receiving IV paracetamol attained conversion to non-hsPDA.
25.0% (7.3–52.4%) in the IV ibuprofen group showed similar improvement.
The difference was not prominent (p = 0.704).

There were no vital differences between groups in short- or medium-term neonatal complications and adverse drug effects or safety outcomes.

Conclusion

For alleviating hsPDA in preterm neonates, IV paracetamol and IV ibuprofen illustrated comparable efficacy and safety. Importantly, the study confirms the feasibility of a large-scale RCT, although further investigation with a larger sample size is warranted to substantiate these findings.