PAIR (Paracetamol and Ibuprofen Research) Pilot Trial

Summary

Presence of Patent Ductus Arteriosus is detrimental to an infant born prematurely. The primary objective is to study the efficacy of Paracetamol (proposed new treatment) in treating haemodynamic significant Patent Ductus Arteriosus (hsPDA) in comparison to Ibuprofen (current standard treatment) in preterm infants. Outcome of such treatment will check on the conversion of hsPDA to non-hsPDA. All preterm infants (born at \<32 weeks gestational age or birth weight \< 1500 grams) with haemodynamically significant patent ductus arteriosus (hsPDA) who are ≤ 28 days old will be included over 2 years. Sample size 32. Secondary outcomes of this study will compare 1\) BPD (broncho-pulmonary dysplasia) free survival at 36 weeks post menstrual age (PMA), 2) incidence of complications of prematurity in each group and 3) to record any evidence of adverse effects with Paracetamol or Ibuprofen.

Timeline

Start

2021-09-03

Primary completion

2023-12-01

Completion

2024-01-01

Publications

• Mukherjee A, Gupta A, Fullwood C, Gottstein R. Paracetamol or ibuprofen? A pilot study comparing rescue therapy for PDA in preterm infants within the first month. Front Pediatr. 2026 Jan 2;13:1717284. doi: 10.3389/fped.2025.1717284. eCollection 2025.

Drugs

Indications