The SAINT Trial: Surfactant by supraglottic Airway versus direct laryngoscopy IN late preterm and Term newborns

INTERVENTION: Supraglottic Airway Group 200mg/kg (2.5ml/kg) poractant alfa (Curosurf ®) surfactant administered via delivery tube following insertion of i‐gel® supraglottic airway device. The intervention will be delivered by either a Consultant Neonatologist, Neonatal Nurse Practitioner or a trainee Neonatal Registrar with the required clinical experience and expertise to undertake the task. The i‐gel is indicated for use in securing and maintaining a patent airway in routine and emergency anaesthetics. It provides a non‐inflatable, anatomical seal of the pharyngeal, laryngeal and perilaryngeal structures and has been recommended as an alternative to direct laryngoscopy and endotracheal intubation in newborn infants by the American Academy of Pediatrics. The i‐gel will remain in position after surfactant administration until the newborn infants is clinically stable. This vary between infants from 1‐5 minutes. CONDITION: Reproductive Health and Childbirth ‐ Complications of newborn Respiratory ‐ Other respiratory disorders / diseases Respiratory Distress Syndrome; ; Respiratory Distress Syndrome PRIMARY OUTCOME: The primary outcome will be assessed on a hypothesis of non‐inferiority. The primary outcome is:; • Respiratory severity score (mean airway pressure x FiO2) ; ; Mean airway pressure will be the recorded from the medical records (either continuous pressure delivered via nasal continuous positive airway pressure (CPAP) or via high‐flow nasal prongs. FiO2 will be recorded from the medical record and the fraction of inspired oxygen required to maintain the newborns oxygen saturation within normal limits. Normal saturation are defined as 90‐94% for infants 34‐36 weeks gestation and 94‐98 for infants greater than 36 weeks gestation.; [6 hours following surfactant administration] SECONDARY OUTCOME: Administration of >/= 2 surfactant doses. This will be determined from the newborns medication chart.[Up to 6 hours post surfactant administration] Device (supraglottic airway, endotracheal tube, thin catheter) insertion attempts. This will be determined from the medical record.[Up to point of surfactant adminsitration] Duration and extent of desaturation from baseline calculated as area‐under‐the curve where x = duration (seconds) and y = desaturation from baseline (%SpO2) during procedure. %SpO2 will be measured by a massimo pulse oximeter and recorded for the duration of the intervention prior to downloading using custom software.[10 minutes post surfactant administration] Number of doses of additional muscle relaxant or sedative during procedure (where used). This will be determined from the newborns medication chart.[up to point of surfactant adminstration] INCLUSION CRITERIA: Infants are eligible for inclusion in the study if: • They are born at >33 weeks GA by best obstetric estimate and have a birth weight of >1500g; and • They are <24 hours old at the time of randomisation; and • They require nasal continuous positive airway pressure (nCPAP) after admission for moderate‐to‐severe respiratory distress, hypoxia or hypercapnia where the treating clinician has determined surfactant therapy is indicated and it is felt unlikely ongoing mechanical ventilation is required.