T r i a l    S u m m a r y

The INNOVO Trial is a randomized controlled trial comparing giving ventilatory support with inhaled nitric oxide (INO) against ventilatory support without inhaled nitric oxide for neonates with severe but potentially reversible respiratory failure.  The overall hypothesis to be tested is that adding INO to the ventilator gases reduces the risk of substantive adverse clinical outcomes, and is cost-effective.  Previous work has suggested that INO can improve oxygenation in the short-term, but little reliable information is yet available about its long-term implications.  A pilot INNOVO Trial has been conducted to guide the protocol for the main INNOVO Trial detailed here.   Based on this experience the entry criteria will not be restrictive but will be allowed to reflect current clinical practice, with centres recruiting to the preterm, term and near term, or both strata.

The primary outcome measures are:

     (a) death or severe disability at the age of one year (corrected), and

          (b) death or on supplemental oxygen on the expected date of delivery
            (or 28 days post-delivery for the full or near term babies).

A total sample size of 200 preterm babies (<34 weeks) will be sufficient to reliably detect important effects on these outcomes and the 110 term or near term babies ( 34 weeks) recruited over the same period will provide useful data which could be added to meta-analyses.

Sub-studies are also in place to consider other developmental and respiratory outcomes, cost-effectiveness, dose response of preterm babies, pathology, toxicology, respiratory function and views of trial participants.