Efficacy of minimally invasive surfactant therapy in moderate and late preterm infants: A multicentre randomized control trial

Abstract

Background: Minimally invasive surfactant therapy (MIST) is a new strategy to avoid mechanical ventilation (MV) in respiratory distress syndrome. The primary aim of this study was to test MIST as a means of avoiding MV exposure and pneumothorax occurrence in moderate and late preterm infants (32 to 36 weeks' gestational age).

Methods: This was a randomized controlled trial including three Canadian centres. Patients were randomized to standard management or to the intervention if they required nasal continuous positive airway pressure of 6 cm H₂O and 35% FiO₂ in the first 24 hours of life. Patients from the intervention group received MIST immediately after inclusion. The primary outcome was either need for MV or development of a pneumothorax requiring a chest tube. To ensure that clinicians were not biased toward delaying intubation in the intervention group, clinical failure criteria were also used as a primary outcome. The primary outcome was analyzed using bivariate and multivariate logistic regressions.

Results: Among 45 randomized patients, 24 were assigned to MIST and 21 to standard management. Eight infants (33%) from the intervention group met the primary outcome criteria versus 19 (90%) in the control group (absolute risk reduction 0.57, 95% confidence interval 0.54 to 0.60). One patient in each group reached the primary outcome because of pneumothorax occurrence. The other patients were exposed to MV. None of the patients reached the clinical failure criteria.

Conclusion: MIST for respiratory distress syndrome management in moderate and late preterm infants was associated with a significant reduction of MV exposure and pneumothorax occurrence.

Keywords: Hyaline membrane disease; Infant; Premature; Pulmonary surfactants; Respiratory distress syndrome; Spontaneous breathing..

Figure 1.

Flow diagram. ¹Among these, 27 were outborn patients and 4 patients were intubated in delivery room. ²One patient presented with severe RDS and was intubated because parents were not available to consent to the study. Clinicians decided not to delay surfactant administration. ³Four eligible patients developed a pneumothorax prior to inclusion and randomization. ⁴Three patients were not included by involuntary omission of the attending physician to recruit them. Three patients were intubated soon after NICU admission because the clinician judged that attempting MIST was not appropriate as the infants had a poor respiratory drive. One patient was intubated because the RDS diagnosis was not obvious. ⁵One patient developed a pneumothorax after he was intubated. MIST Minimally invasive surfactant therapy; MV Mechanical ventilation; N Number; NICU Neonatal intensive care unit; RDS Respiratory distress syndrome.