The OPTIMIST-A trial: evaluation of minimally-invasive surfactant therapy in preterm infants 25-28 weeks gestation.

BACKGROUND: It is now recognized that preterm infants ≤28 weeks gestation can be effectively supported from the outset with nasal continuous positive airway pressure. However, this form of respiratory therapy may fail to adequately support those infants with significant surfactant deficiency, with the result that intubation and delayed surfactant therapy are then required. Infants following this path are known to have a higher risk of adverse outcomes, including death, bronchopulmonary dysplasia and other morbidities. In an effort to circumvent this problem, techniques of minimally-invasive surfactant therapy have been developed, in which exogenous surfactant is administered to a spontaneously breathing infant who can then remain on continuous positive airway pressure. A method of surfactant delivery using a semi-rigid surfactant instillation catheter briefly passed into the trachea (the "Hobart method") has been shown to be feasible and potentially effective, and now requires evaluation in a randomised controlled trial. METHODS/DESIGN: This is a multicentre, randomised, masked, controlled trial in preterm infants 25-28 weeks gestation. Infants are eligible if managed on continuous positive airway pressure without prior intubation, and requiring FiO2 ≥ 0.30 at an age ≤6 hours. Randomisation will be to receive exogenous surfactant (200 mg/kg poractant alfa) via the Hobart method, or sham treatment. Infants in both groups will thereafter remain on continuous positive airway pressure unless intubation criteria are reached (FiO2 ≥ 0.45, unremitting apnoea or persistent acidosis). Primary outcome is the composite of death or physiological bronchopulmonary dysplasia, with secondary outcomes including incidence of death; major neonatal morbidities; durations of all modes of respiratory support and hospitalisation; safety of the Hobart method; and outcome at 2 years. A total of 606 infants will be enrolled. The trial will be conducted in >30 centres worldwide, and is expected to be completed by end-2017. DISCUSSION: Minimally-invasive surfactant therapy has the potential to ease the burden of respiratory morbidity in preterm infants. The trial will provide definitive evidence on the effectiveness of this approach in the care of preterm infants born at 25-28 weeks gestation. TRIAL REGISTRATION: Australia and New Zealand Clinical Trial Registry: ACTRN12611000916943; ClinicalTrials.gov: NCT02140580.

Respiratory function monitor guidance of mask ventilation in the delivery room: a feasibility study.

OBJECTIVE: To investigate whether using a respiratory function monitor (RFM) during mask resuscitation of preterm infants reduces face mask leak and improves tidal volume (V(T)). STUDY DESIGN: Infants receiving mask resuscitation were randomized to have the display of an RFM (airway pressure, flow, and V(T) waves) either visible or masked. RESULT: Twenty-six infants had the RFM visible, and 23 had the RFM masked. The median mask leak was 37% (IQR, 21%-54%) in the visible RFM group and 54% (IQR, 37%-82%) in the masked RFM group (P = .01). Mask repositioning was done in 19 infants (73%) of the visible group and in 6 infants (26%) of the masked group (P = .001). The median expired V(T) was similar in the 2 groups. Oxygen was provided to 61% of the visible RFM group and 87% of the RFM masked group (P = .044). Continuous positive airway pressure use was greater in the visible RFM group (73% vs 43%; P = .035). Intubation in the delivery room was done in 21% of the visible group and in 57% of the masked group (P = .035). CONCLUSION: Using an RFM was associated with significantly less mask leak, more mask adjustments, and a lower rate of excessive V(T).