Paracetamol vs. Ibuprofen in Preterm Infants With Hemodynamically Significant Patent Ductus Arteriosus: A...

Area of Science:

• Neonatalogy
• Pharmacology
• Clinical Trials

Background:

• Current first-line treatments for persistent ductus arteriosus (PDA), indomethacin and ibuprofen, carry significant risks.
• There is a need for safer alternatives to manage PDA in preterm infants.
• Clinical evidence supporting paracetamol for PDA management is limited, necessitating further investigation.

Purpose of the Study:

• To evaluate the efficacy and safety of intravenous paracetamol compared to intravenous ibuprofen for PDA treatment in preterm neonates.
• To determine if paracetamol is non-inferior to ibuprofen in achieving ductus closure.
• To assess both short-term and long-term outcomes, including neurodevelopmental follow-up.

Main Methods:

• A randomized, multicenter, double-blind, non-inferiority study design.
• Preterm patients with gestational age ≤ 30 weeks randomized 1:1 to receive IV paracetamol or IV ibuprofen.
• Primary endpoint: ductus closure after the first treatment course; secondary endpoints include safety, effectiveness, and long-term neurodevelopmental assessment (Bayley III).

Main Results:

• The study is designed to compare the primary endpoint of ductal closure rates between the two treatment groups.
• Secondary endpoints will provide comprehensive data on treatment effectiveness, including re-opening rates and need for surgery.
• Safety and long-term outcomes, including neurodevelopmental assessment up to 24 months corrected age, will be rigorously evaluated.

Conclusions:

• This trial aims to establish whether intravenous paracetamol can be a safe and effective alternative for PDA treatment.
• Results will inform clinical practice guidelines regarding PDA management in preterm infants.
• The study will contribute crucial data on the long-term safety and efficacy of paracetamol in this vulnerable population.