PAIR (Paracetamol and Ibuprofen Research) Pilot Trial

Launched by MANCHESTER UNIVERSITY NHS FOUNDATION TRUST · Jul 29, 2021

Keywords

ClinConnect Summary

The PAIR (Paracetamol and Ibuprofen Research) Pilot Trial is studying how effective Paracetamol is in treating a condition called Patent Ductus Arteriosus (PDA) in premature infants, compared to the standard treatment, which is Ibuprofen. PDA is a heart condition that can cause serious problems for babies born too early, especially if it affects their blood flow. This trial aims to see if Paracetamol can help more infants transition from a severe form of PDA to a less serious form. The study will include preterm infants who are either born before 32 weeks of pregnancy or weigh less than 1500 grams and are no older than 28 days.

To be eligible for the trial, infants must meet specific criteria, such as having a significant PDA that needs treatment. However, some infants will not be able to participate if they have certain health issues, like bleeding problems or serious congenital heart defects. Over the course of two years, researchers will monitor 32 infants to see how well both medications work and if they cause any side effects. If your baby qualifies, the trial will provide a chance to contribute to important research that could improve treatment options for other premature infants in the future.

Gender

ALL

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.