Background/aims The pathogenesis of BPD is multifactorial. In preterm infants ≤28 wk GA requiring ventilation at 7–14 days, >60% have surfactant dysfunction. Survival without BPD in these infants is <25%. Inhaled nitric oxide (iNO) may improve outcome in some infants (Schreiber, NEJM 2003, Ballard NEJM, 2006).
Methods Preterm infants ≤28 wk GA requiring mechanical ventilation at 7–14 days were enrolled in a RCT at 25 US centres. All infants received iNO and were randomised to receive surfactant (Infasurf) or sham instillation behind a screen every 1–2 days; maximum of 5 doses. Infants were evaluated by physiologic oxygen/flow reduction at 36 and 40 wk. Pulmonary outcome to 18 months is being collected.
Results Between January 2010 and September 2013, 511 of the planned 524 infants were enrolled. There was no difference between groups in mean BW (701 ± 164 grams), GA (25.2 ± 1.2 wk), percentage under 26 wk (70.6%), race, gender, severity of disease at enrollment or co-morbidities of prematurity. Survival without BPD was not different between treated vs. controls at 36 wk (31.3% vs.31.7%; relative benefit 0.98 (0.75, 1.28 p = 0.89) or 40 wk (58.7% vs. 54.1%; relative benefit 1.08 (0.92, 1.27 p = 0.33). Overall survival without BPD at 36wk in African Americans was better than whites (37.2% vs. 25.4%p = 0.008).
Conclusions Late treatment with surfactant in ventilated preterm infants did not improve survival without BPD at 36 or 40 weeks PMA. Overall better outcome in African-American infants may be due to a racial response to iNO. Pulmonary and neurodevelopmental assessment are on-going.