Effect of surfactant dose on outcomes in preterm infants with respiratory distress syndrome: the OPTI-SURF study protocol.

Respiratory distress syndrome is a condition seen in preterm infants primarily due to surfactant insufficiency. European guidelines recommend the dose and method of surfactant administration. However, in routine practice, clinicians often use a 'whole vial' approach to surfactant dosing. The aim of this study is to assess whether in preterm infants of gestational age 36 In this prospective, observational study, we will use the National Neonatal Research Database as the main data source. We will obtain additional information describing the dose and method of surfactant administration through the neonatal EPR system. We will use propensity scores to form matched groups with low first dose and high first dose for comparison. This study was approved by the West Midlands-Black Country Research Ethics Committee (REC reference: 18/WM/0132; IRAS project ID: 237111). The results of the research will be made publicly available through presentations at local, national or international conferences and will be submitted for publication in a peer-reviewed journal. NCT03808402; Pre-results.

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Déclaration de conflit d'intérêts

Competing interests: KCWG is chief investigator for the OPTI-SURF study. He reports receiving personal fees from Chiesi Pharmaceuticals outside of the submitted work to support attendance at an educational meeting. CG reports grants from Medical Research Council and the National Institute for Health Research, Mason Medical Research Foundation, Rosetrees Foundation and Canadian Institute for Health Research outside this work. He reports receiving personal fees from Chiesi Pharmaceuticals outside of the submitted work to support attendance at educational meetings. NM is the director of the Neonatal Data Analysis Unit and the chief investigator for the National Neonatal Research Database. She is a trustee of the David Harvey Trust, Medical Women’s Federation and Action Cerebral Palsy and Their World, and is a member of the Nestle Scientific Advisory Board. She reports research grants in the last 5 years from the British Heart Foundation, Medical Research Council, National Institute of Health Research, Westminster Research Fund, Collaboration for Leadership in Applied Health and Care Northwest London, Healthcare Quality Improvement Partnership, Bliss, Nestle, Prolacta Life Sciences, Chiesi, Shire and HCA International; travel and accommodation expenses from Prolacta, Nestle and Chiesi; and a lecture honorarium from Chiesi. NL is senior statistician at the Neonatal Data Analysis Unit. He reports no competing interests. RM and KR are full-time employees of Chiesi.