Oral ibuprofen showed no 2-year developmental advantage, but equivalence remains unproven
In 130 survivors randomized at postnatal days 6 to 14, neurodevelopmental impairment was 10/66 (15%) without ibuprofen and 14/64 (22%) with it (P = .371). With 22% power for that comparison, the follow-up supports uncertainty, not equivalence.
The hot take
The study found no developmental advantage for ibuprofen. Its 22% power makes equivalence the wrong conclusion.
This 2026 report follows survivors from a single-center, double-blind, placebo-controlled randomized trial. Infants born at 23 to 30 weeks with a PDA greater than 1.5 mm and a need for respiratory support were assigned between postnatal days 6 and 14 to placebo and nonintervention or oral ibuprofen at 10 mg/kg followed by 5 mg/kg at 24 and 48 hours. The report describes 2-year neurodevelopmental impairment as the prespecified follow-up outcome.
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146 randomized
Infants were assigned to nonintervention or oral ibuprofen.
- 2
142 in the parent per-protocol analysis
Four infants assigned to ibuprofen were excluded after not completing all three doses; 72 and 70 infants remained.
- 3
12 hospital deaths
Six deaths occurred in each analyzed group.
- 4
130 survivors followed
The 2-year cohort included 66 without ibuprofen and 64 with ibuprofen.
- 5
118 completed BSID-II
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