PAIR (Paracetamol and Ibuprofen Research) Pilot Trial

• Status: Recruiting
• Trial end date: 2024-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Manchester University NHS Foundation Trust
• Treatments: Acetaminophen; Ibuprofen

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.