Delivery-Room Prophylactic Thin-Catheter Surfactant in Extremely Preterm Infants: A Multicentre Pilot Randomised...

To determine the effectiveness and feasibility of prophylactic thin-catheter surfactant (TC-S) in the delivery room in preventing intubation and mechanical ventilation in the first week after birth in extreme preterm infants.

The Extreme Preterm Infants Non-invasive Surfactant Trial (EPINIST) was a pilot randomised controlled trial conducted from 2018 to 2023. We included infants from 24⁺⁰ to 27⁺⁶ weeks' gestation with valid informed consent obtained before delivery. Infants who were unlikely to survive, had congenital anomalies affecting breathing or survival or whose mothers had clinical chorioamnionitis or mid-second-trimester prolonged rupture of membranes were excluded. Infants were randomised to nasal continuous positive airway pressure with prophylactic TC-S while spontaneously breathing (intervention arm) or intubation, prophylactic surfactant and brief mechanical ventilation (ETT-S; control arm). The primary outcome measures were the need for intubation and mechanical ventilation within the first week after birth, as well as the occurrence of serious adverse events during the intervention.

Sixty-two infants were randomised, 33 infants to the TC-S and 29 infants to the intubation and surfactant group. Of the infants randomised to the TC-S group, only 11 (33.3%) required intubation and mechanical ventilation within the first week after birth, compared with 28 (96.6%) in the ETT-S group. No severe adverse events were noted in the TC-S group.

Delivery-room prophylactic TC-S was feasible and reduced exposure to protocol-directed mechanical ventilation. A larger definitive trial powered for clinical outcomes is warranted.

Australia and New Zealand Clinical Trials Registry: ACTRN12617001204336p.