Expectant management non-inferior to early ibuprofen in premature infants with PDA

Amsterdam: A study has concluded that the expectant management for patent ductus arteriosus (PDA) was non-inferior to early ibuprofen treatment concerning necrotizing enterocolitis, bronchopulmonary dysplasia, or death at 36 weeks postmenstrual age in extremely premature infants.

The study's findings are published in the New England Journal of Medicine.

It is already known that Cyclooxygenase inhibitors are used in infants commonly with patent ductus arteriosus (PDA). There needs to be more data as the beneficial effect of these drugs remains uncertain.

To add more data, a study was conducted by a team of researchers led by Tim Hundscheid, M.D. from the Department of Pediatrics and the Department for Health Evidence.

The study points are:

• The study was a multicenter, noninferiority trial.
• The infants (extremely preterm of gestational age <28 weeks) with echocardiographically confirmed PDA (diameter>1.5 mm, with left-to-right shunting) were randomly assigned.
• The infants were given either expectant management or early ibuprofen treatment.
• Necrotizing enterocolitis (Bell's stage IIa or higher), bronchopulmonary dysplasia (moderate to severe), or death at 36 weeks postmenstrual age were the composite primary outcome included in the study.
• A total of 273 infants underwent randomization of median gestational age and birth weight of 26 weeks and 845 g.
• In the expectant management group and early-ibuprofen group, a primary-outcome event occurred in 46.3% and 63.5%, respectively.
• The absolute risk difference was −17.2 percentage points.
• In the expectant-management group and the early-ibuprofen group, Necrotizing enterocolitis occurred in 17.6 % and 15.3 % of infants, with an absolute risk difference of 2.3 percentage points. Bronchopulmonary dysplasia occurred in 33.3% of infants and 50.9% of infants, respectively, with an absolute risk difference of −17.6 percentage points.
• In the expectant management and the early-ibuprofen group, death occurred in 14.0% and 18.2% of infants, respectively, with an absolute risk difference of −4.3 percentage points.
• There were similar Rates of other adverse outcomes in both groups.

They said that expectant management was non-inferior to early ibuprofen treatment for PDA in extremely premature infants.

The study was funded by the Netherlands Organization for Health Research and Development and the Belgian Health Care Knowledge Center.

The researchers thanked parents who gave consent to infants for participation in the trial.

Further reading:

Expectant Management or Early Ibuprofen for Patent Ductus Arteriosus. Tim Hundscheid et al.