OPTIMIST trials

Multicentre, randomised, masked, controlled trials of surfactant administration via tracheal catheterisation in preterm infants on CPAP.

Research question

Does administration of exogenous surfactant using a minimally-invasive technique improve outcome in preterm infants treated with continuous positive airway pressure (CPAP)?

Background

Nasal CPAP is often very effective in preterm infants as the initial means of respiratory support, but a sub-group of infants, most with features of respiratory distress syndrome, fail on CPAP and require intubation and ventilation in the first 72 hours. When compared to those in whom CPAP is successful, infants failing CPAP have a substantially longer duration of respiratory support, and a higher risk of adverse outcomes.Decreasing the risk of CPAP failure would thus seem advantageous, and may be achievable with minimally invasive surfactant therapy (MIST), in which surfactant is administered to a spontaneously breathing infant who then remains on CPAP. A technique of MIST (the "Hobart method"), in which the trachea is catheterised using a semi-rigid surfactant instillation catheter, has been shown to be feasible in preterm infants on CPAP, and appears to have the potential to alter respiratory course and outcome. This method of MIST now requires evaluation in randomised controlled trials.

The OPTIMIST trials

The OPTIMIST trials are paired randomised controlled trials of surfactant administration via MIST in preterm infants of two different gestation ranges. The intervention will be masked from treating clinicians. The trials will give definitive information about the place of MIST in preterm infants on CPAP.

For more information please click on one of the following links:

• OPTIMIST-A trial
• OPTIMIST-B trial