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.
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.