Comparing Paracetamol and Ibuprofen for treating heart issues in premature infants

PAIR (Paracetamol and Ibuprofen Research) Study: A Randomised Controlled Trial Comparing IV Paracetamol With IV Ibuprofen in the Management of Haemodynamically Significant Patent Ductus Arteriosus

This study is testing whether intravenous Paracetamol is as effective as intravenous Ibuprofen for treating heart issues in premature infants with a condition called hsPDA.

Quick facts

• Phase: Phase2; Phase3
• Study type: Interventional
• Enrollment: 32 (estimated)
• Ages: 23 Weeks to 32 Weeks
• Sex: All
• Sponsor: Manchester University NHS Foundation Trust (Government)
• Locations: 1 site (Manchester)
• Trial ID: NCT04986839 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness of intravenous Paracetamol compared to intravenous Ibuprofen in treating haemodynamically significant Patent Ductus Arteriosus (hsPDA) in preterm infants. The study will include infants born at less than 32 weeks gestation or weighing less than 1500 grams, who are 28 days old or younger and meet the criteria for hsPDA. Over a two-year period, the trial will assess the conversion of hsPDA to non-hsPDA and monitor secondary outcomes such as bronchopulmonary dysplasia-free survival and any adverse effects associated with the treatments. A total of 32 infants will be enrolled to provide insights into the safety and efficacy of Paracetamol as a potential alternative to the current standard treatment.

Who should consider this trial

Good fit: Ideal candidates for this study are preterm infants born at less than 32 weeks gestation or weighing less than 1500 grams, who are 28 days old or younger and diagnosed with hsPDA.

Not a fit: Patients with contraindications for either Ibuprofen or Paracetamol, or those with certain severe medical conditions, may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a safer and more effective treatment option for preterm infants with hsPDA.

How similar studies have performed: While the use of Paracetamol for treating PDA has shown promising results, the current body of evidence is considered moderate to low quality, indicating that this approach is still under investigation.

Eligibility criteria

Inclusion Criteria:

* Gestational age - \<32 weeks OR birth weight \< 1500 grams
* Postnatal age ≤ 28 days
* Meets criteria for hsPDA
* Clinician's decision to treat PDA

Exclusion Criteria:

* Contraindication for administration of Ibuprofen (cyclooxygenase-inhibitors) or Paracetamol, such as: active bleeding (e.g. intracranial or gastrointestinal haemorrhage), thrombocytopenia (\<50x109/L), renal failure (raised creatinine (\>100 micromole/l) or oliguria (\<0.5 mL/kg/hour), known or suspected necrotising enterocolitis, any gastric or intestinal perforation, pre-treatment abnormal liver function tests (ALT \> upper normal limit of the reference range, Bilirubin \> National Institute of Clinical Excellence exchange phototherapy level).
* Previous use of Ibuprofen or Paracetamol prior to randomisation.
* Persistent pulmonary hypertension (ductal right-to-left shunt ≧33% of cardiac cycle).
* Congenital heart defect, other than PDA or Patent Foramen Ovale (PFO).
* Life-threatening congenital birth defects.
* Chromosomal abnormalities and/or congenital anomalies associated with abnormal neurodevelopment.

Where this trial is running

Manchester

• Manchester University NHS Foundation Trust — Manchester, United Kingdom (Recruiting)

Study contacts

• Principal investigator: Arin Mukherjee, MRCPCH — Manchester University NHS Foundation Trust
• Study coordinator: Karen Dockery

Conditions Patent Ductus Arteriosus