PAIR (Paracetamol & Ibuprofen Research) Pilot Trial

Status Recruiting

Clinical 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.

Clinical Trial Description

Patent Ductus Arteriosus (PDA) is present in 40-60 percent of preterm infants. A persistent PDA with a large left to right ductal shunt may be 'haemodynamically significant' (hsPDA) resulting in pulmonary hyper-perfusion and systemic hypo-perfusion. The association of a PDA with an increased incidence of pulmonary haemorrhage, bronchopulmonary dysplasia and prolonged need for ventilatory support is ascribed to pulmonary hyper-perfusion, whereas necrotising enterocolitis, renal failure, cerebral haemorrhage, and periventricular leukomalacia are consequences of systemic hypo-perfusion. In the United Kingdom, Ibuprofen (a non-steroidal anti-inflammatory drug, NSAID) is used to treat hsPDA in preterm babies. Paracetamol has come up recently as a promising alternative with fewer side effects and has been used in the management of PDA with promising results. However, the current available body of evidence is considered to be of moderate to low quality and hence its effectiveness and safety profile is not fully established in this patient population. The primary objective is to study the efficacy of IV paracetamol in treating hsPDA in comparison to IV ibuprofen in preterm infants born at less than 32 weeks' gestation OR less than 1500 grams birth weight. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04986839
Study type	Interventional
Source	Manchester University NHS Foundation Trust
Contact	Karen Dockery
Phone	0161 276 3863
Email	karen.dockery@cmft.nhs.uk
Status	Recruiting
Phase	Phase 2/Phase 3
Start date	September 3, 2021
Completion date	January 1, 2024

View Details

See also
Status	Clinical Trial	Phase
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Completed	`NCT03551600` - Splanchnic and Renal Tissue Oxygenation During Enteral Feedings in Neonates With Patent Ductus Arteriosus
Terminated	`NCT03982342` - Preliminary Percutaneous Intervention Versus Observational Trial of Arterial Ductus in Low-weight Infants	N/A
Completed	`NCT01479218` - Safety and Effectiveness Study With a New PDA Occluder for Closure of Patent Ductus Arteriosus	N/A
Completed	`NCT00795990` - Timing for the Medical Treatment of Patent Ductus Arteriosus in Preterm Infants	N/A
Terminated	`NCT00802685` - Timing of PDA Closure and Respiratory Outcome in Premature Infants	N/A
Withdrawn	`NCT00554307` - Brain, Gut and Kidney Blood Flow During Medical Closure of PDA	N/A
Completed	`NCT03723889` - Patent Ductus Arteriosus and Splanchnic Oxygenation at First Feed
Recruiting	`NCT04397913` - Population Pharmacokinetics and Dosage Individualization of Paracetamol and Ibuprofen in Children With PDA
Completed	`NCT02750228` - PDA Post NICU Discharge
Recruiting	`NCT02220270` - Hyperion™ International Registry Trial	N/A
Completed	`NCT01593163` - Echocardiographically Guided Versus Standard Ibuprofen Treatment for Patent Ductus Arteriosus	Phase 3
Recruiting	`NCT06298344` - The Role of Thiamine After Transcatheter Closure in Children With Left-to-Right Shunt Congenital Heart Disease	Early Phase 1
Completed	`NCT03277768` - Non-Invasive Detection of Tissue Oxygen Deprivation in Premature Infants With Patent Ductus Arteriosus.
Completed	`NCT03022253` - Platelet Transfusion for Treatment of Patent Ductus Arteriosus in Thrombocytopenic Preterm Neonates	Phase 3

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

PAIR (Paracetamol and Ibuprofen Research) Pilot Trial — PAIR

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms