High-Frequency Oscillatory Ventilation Combined With Inhaled Nitric Oxide for Persistent Pulmonary Hypertension of the Newborn: A Single-Center Randomized Clinical Trial
Abstract
Background: Persistent pulmonary hypertension of the newborn (PPHN) may respond incompletely to inhaled nitric oxide (iNO) when poorly recruited lung limits delivery to ventilated alveoli. We evaluated whether high-frequency oscillatory ventilation (HFOV) combined with iNO improved clinical and physiologic outcomes compared with conventional mechanical ventilation (CMV) + iNO or HFOV alone.
Methods: In this prospective, single-center, 3-arm, open-label randomized clinical trial, 138 neonates born at 34 weeks of gestation or later with echocardiographically confirmed PPHN and an oxygenation index of 25 or greater were randomized 1:1:1 to HFOV + iNO, CMV + iNO, or HFOV alone. The principal complete-case per-protocol analysis included 126 infants (42 per group) with ascertainable 120-day primary outcomes who completed the assigned strategy without a major protocol deviation. The possible influence of the 12 unavailable primary outcomes was evaluated in post hoc randomized-denominator extreme-case sensitivity analyses. The primary outcome was death or extracorporeal membrane oxygenation (ECMO) within 120 days.
Results: In the complete-case per-protocol population, death or ECMO occurred in 3 of 42 infants (7.1%) assigned to HFOV + iNO, 11 of 42 (26.2%) assigned to CMV + iNO, and 14 of 42 (33.3%) assigned to HFOV alone (overall p = 0.012). For HFOV + iNO versus CMV + iNO, the risk ratio was 0.27 (95% CI, 0.08-0.91), and the risk difference was -19.0 percentage points (95% CI,…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 126 participants or records.
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