The European Nitric Oxide study has just published the 2 year outcomes of their trial. The original trial was one of the studies of routine NO administration to preterm babies. In this RCT 800 infants, <29 weeks gestation, with mild/moderate respiratory distress were given 5 ppm of NO for 7 to 21 days o placebo. There was no effect on the primary outcome of survival without BPD.
This new report describes the 2 year outcomes of 630 of the 685 babies who were alive at 2 years. The Bayley 3 scores were identical between the groups, and all other adverse neurologic outcomes, and adverse health outcomes were also similar.
As we noted in the IPD meta-analysis that we published, this trial was similar to the other ‘early prophylaxis’ trials, but also had significant differences. Partly as infants who had severe disease were excluded, (if they needed more than 50% oxygen) and they could be included if on CPAP at randomization, if they needed at least 30% O2.
I think there is now probably no role for routine iNO in early life as primary prevention of BPD. The results of a follow up trial to the Ballard study should not be too long in coming I think, the trial has stopped enrolling according to the clinical trials.gov website. that study is for infants, 500 to 1250 g, who continue to have significant respiratory support at 5 to 14 days of age and get 20 ppm of iNO for about 24 days.
Use to rescue preterm infants with serious respiratory failure in early life is also not currently supported by the literature, although there may be subgroups (such as those with pulmonary hypertension) who might benefit, and should probably be studied.