High-dose ibuprofen for patent ductus arteriosus in extremely preterm infants: a randomized controlled study

C Dani1, V Vangi, G Bertini

  • 1Department of Surgical and Medical Critical Care, Section of Neonatology, Careggi University Hospital of Florence, Florence, Italy. cdani@unifi.It

Insights

High-dose ibuprofen effectively closes patent ductus arteriosus (PDA) in preterm infants without increasing adverse effects. This high-dose regimen offers a superior treatment option for managing PDA in premature neonates.

Area of Science:

  • Neonatal medicine
  • Pediatric cardiology
  • Pharmacology

Background:

  • Patent ductus arteriosus (PDA) is common in preterm infants, especially those with respiratory distress syndrome (RDS).
  • Standard-dose ibuprofen is a common treatment, but its efficacy can be limited.
  • The optimal ibuprofen dosage for PDA closure in extremely preterm infants remains under investigation.

Purpose of the Study:

  • To compare the efficacy and safety of a high-dose ibuprofen regimen versus a standard-dose regimen for PDA closure.
  • To determine if a higher dose of ibuprofen improves PDA closure rates without increasing adverse events in very preterm infants.

Main Methods:

  • A randomized controlled trial involving 70 infants with gestational age <29 weeks and echocardiographic evidence of significant PDA.
  • Infants were randomized to receive either a standard (10-5-5 mg/kg/day) or high-dose (20-10-10 mg/kg/day) course of ibuprofen.
  • Echocardiography was used to assess PDA status and adverse effects.

Main Results:

  • The high-dose ibuprofen group showed a significantly lower rate of persistent PDA (14%) compared to the standard-dose group (37%) (P = 0.03).
  • No significant differences in adverse effects were observed between the standard-dose and high-dose ibuprofen treatment groups.
  • The high-dose regimen demonstrated superior efficacy in achieving PDA closure.

Conclusions:

  • A high-dose ibuprofen regimen is more effective than the standard-dose regimen for closing PDA in preterm infants <29 weeks gestation.
  • The increased efficacy of high-dose ibuprofen does not appear to be associated with a higher rate of adverse effects.
  • High-dose ibuprofen represents a potentially improved therapeutic strategy for managing PDA in this vulnerable population.