Oral Ibuprofen and ductus arteriosus in premature infants: a randomized pilot study

Hany Aly1, Wael Lotfy, Nadia Badrawi

  • 1Newborn Services Department, The George Washington University Hospital, Washington, District of Columbia 20037, USA.

Insights

Oral ibuprofen suspension (OIS) is a feasible and effective treatment for premature infants with patent ductus arteriosus (PDA). This study found OIS comparable to intravenous indomethacin, with fewer adverse events like pulmonary hemorrhage.

Area of Science:

  • Neonatal Medicine
  • Pediatric Cardiology
  • Pharmacology

Background:

  • Patent ductus arteriosus (PDA) is a common condition in premature infants, often requiring medical intervention.
  • Intravenous indomethacin is a standard treatment, but carries risks and administration challenges.
  • Exploring alternative, easier-to-administer treatments is crucial for improving outcomes in neonates.

Purpose of the Study:

  • To assess the feasibility and efficacy of oral ibuprofen suspension (OIS) for treating PDA in premature infants.
  • To compare OIS with intravenous (IV) indomethacin in terms of PDA closure rates and safety.
  • To evaluate the impact of both treatments on laboratory parameters and adverse events.

Main Methods:

  • A randomized controlled trial involving premature infants (≤35 weeks) diagnosed with PDA.
  • Infants received either IV indomethacin or OIS.
  • Echocardiography (ECHO) was used to measure ductal parameters before and after treatment.
  • Laboratory values (hematocrit, platelets, BUN, creatinine) and adverse events were monitored.

Main Results:

  • PDA closure rates were high and similar between groups: 78% for IV indomethacin and 83% for OIS.
  • Infants receiving IV indomethacin showed a significant decrease in hematocrit compared to OIS.
  • No infants in the OIS group experienced severe pulmonary hemorrhage, unlike two in the IV indomethacin group.

Conclusions:

  • Oral ibuprofen suspension is a viable and effective alternative for treating PDA in premature infants.
  • OIS demonstrates a favorable safety profile, with a lower incidence of severe pulmonary hemorrhage.
  • The ease of administration makes OIS a promising option for neonatal care.