UMIN000021785.

Study name	Effectiveness of MIST (minimally invasive surfactant therapy) under bronchoscopy in treating neonatal respiratory distress syndrome
Methods	Single‐arm, non‐randomised, open‐label study
Participants	Inclusion criteria: patients fulfilling all of the following criteria will be included Born at Tokyo Women's Medical University Medical Centre East, and admitted to the NICU Diagnosed with respiratory distress syndrome Informed consent obtained from parents Thought to be appropriate for the study by the attending physician Exclusion criteria: patients fulfilling any of the following criteria will be excluded Severe birth asphyxia Multiple malformation syndrome, or other suspected underlying disease Needing vasoactive drugs Tendency to bleed Congenital infection Thought to be inappropriate for the study by the supervising physician
Interventions	To compare surfactant application using 2 techniques MIST (minimally invasive surfactant therapy) via a thin bronchoscope inserted into the trachea without the need for endotracheal intubation or use of a laryngoscope Historical control
Outcomes	Primary outcomes: short‐term prognosis of respiration in patients treated with bronchoscopic MIST including Days under mechanical ventilation Days under supplemental oxygen Incidence of airway disease Need for endotracheal intubation or additional surfactant Secondary outcomes Morbidity of disease often seen in preterm infants (intraventricular haemorrhage, pneumothorax, patent ductus arteriosus, bronchopulmonary dysplasia, sepsis, NEC) Length of hospitalisation, mortality rate
Starting date	January 2016
Contact information	Masanori Wasa, Tokyo Women's Medical University Medical Centre East, 2‐1‐10 Nishiogu, Arakawaku, Tokyo
Notes	Funded by Tokyo Women's Medical University Medical Centre East Recruitment status of this study is (quote) "recruiting" Registered with UMIN‐CTR Clinical Trial (Japan): UMIN000021785, on 5 April 2016

ASQ: age and stage questionnaire; BPD: bronchopulmonary dysplasia; bpm: beats per minute; CLD: chronic lung disease; CPAP: continuous positive airway pressure; CRF: case report form; CSF: cerebrospinal fluid; ECALMIST: Early CPAP And Large Volume Minimal Invasive Surfactant Therapy;ETT: endotracheal tube; FANS: Faceless Acute Neonatal Pain Scale; GA: gestational age; hsPDA: haemodynamically significant patent ductus arteriosus;InSurE: intubate, surfactant, extubate; IVH: intraventricular haemorrhage; LISA: less invasive surfactant administration; LPPSA: A Randomized, Controlled Study in Preterm Neonates With RDS to Compare Two Procedures for PorcineSurfactant (Poractant Alfa, CUROSURF®) Administration: A Less Invasive Method (LISA) and ConventionalAdministration; MIST: minimally invasive surfactant therapy; MISurF: minimally invasive surfactant; MV: mechanical ventilation; nCPAP: nasal continuous positive airway pressure;NEC: necrotising enterocolitis; nHFOV: nasal high‐frequency oscillatory ventilation; NICU: neonatal intensive care unit; NIPPV: nasal intermittent positive‐pressure ventilation; NIRS: near‐infrared spectroscopy; NIV: non‐invasive ventilation; PEEP: positive end‐expiratory pressure; PSC: pulmonary severity score; SAE: serious adverse event; SNIPPV: synchronised nasal intermittent positive‐pressure ventilation technique; StrAAS: Stress Assessment in Preterm Infants With Respiratory Distress Syndrome Treated or Not With an Analgesic Drug During the Traditional or the Less Invasive Method of Surfactant Therapy.