Accepted for Publication: July 27, 2023.
Published Online: September 11, 2023. doi:10.1001/jama.2023.15694
Corresponding Author: Peter A. Dargaville, MD, Department of Paediatrics, Royal Hobart Hospital, 48 Liverpool St, Hobart, TAS 7000, Australia (peter.dargaville@ths.tas.gov.au).
Author Contributions: Dr Dargaville and Ms Orsini had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. The trial coordinating center and data management and statistics center were led by Drs Dargaville and Carlin, respectively.
Concept and design: Dargaville, Kamlin, Orsini, Soll, Carlin, Davis.
Acquisition, analysis, or interpretation of data: Dargaville, Kamlin, Orsini, Wang, De Paoli, Kanmaz Kutman, Cetinkaya, Kornhauser-Cerar, Derrick, Özkan, Hulzebos, Schmölzer, Aiyappan, Lemyre, Kuo, Rajadurai, O’Shea, Biniwale, Ramanathan, Kushnir, Bader, Thomas, Chakraborty, Buksh, Bhatia, Sullivan, Shinwell, Dyson, Barker, Kugelman, Donovan, Goss, Tauscher, Murthy, Ali, Clark, Johnson, Cheong, Carlin, Davis.
Drafting of the manuscript: Dargaville, Orsini, Wang, Kanmaz Kutman, Cetinkaya, Carlin.
Critical review of the manuscript for important intellectual content: Dargaville, Kamlin, Orsini, De Paoli, Kanmaz Kutman, Cetinkaya, Kornhauser-Cerar, Derrick, Özkan, Hulzebos, Schmölzer, Aiyappan, Lemyre, Kuo, Rajadurai, O’Shea, Biniwale, Ramanathan, Kushnir, Bader, Thomas, Chakraborty, Buksh, Bhatia, Sullivan, Shinwell, Dyson, Barker, Kugelman, Donovan, Goss, Tauscher, Murthy, Ali, Clark, Soll, Johnson, Cheong, Carlin, Davis.
Statistical analysis: Orsini, Wang, Carlin.
Obtained funding: Dargaville, Kamlin.
Administrative, technical, or material support: Dargaville, De Paoli, Kanmaz Kutman, Derrick, Hulzebos, Buksh, Donovan, Johnson, Davis.
Supervision: Dargaville, Orsini, Rajadurai, Biniwale, Ramanathan, Kushnir, Chakraborty, Clark, Carlin.
Other–site investigator: Özkan, Schmölzer, Aiyappan, Kuo, Thomas, Sullivan, Dyson, Barker, Kugelman, Goss, Tauscher, Murthy.
Other: Bader.
Conflict of Interest Disclosures: Dr Dargaville reported receiving personal fees from AbbVie (advisory board consultancy 2014) and Chiesi Farmaceutici (advisory board consultancies 2016, 2021) and provision of surfactant at reduced cost and support for conference travel from Chiesi Farmaceutici during the conduct of the study; in addition, Dr Dargaville has a patent for a catheter design (USD752215S) issued. Dr Hulzebos reported receiving grants from Chiesi Farmaceutici during the conduct of the study. Dr Kushnir reported receiving grants from the University of Sydney outside the submitted work. Dr Goss reported serving as chief investigator for OPTI-SURF, an observational study on UK neonatal surfactant use in respiratory distress syndrome funded by Chiesi UK outside the submitted work. Dr Clark reported receiving personal fees from Chiesi Farmaceutici outside the submitted work. No other disclosures were reported.
Funding/Support: This study was funded by grants from the Royal Hobart Hospital Research Foundation (#11-382; #21-202) and the Australian National Health and Medical Research Council (#1049114). Exogenous surfactant was provided at reduced cost by Chiesi Farmaceutici.
Role of the Funder/Sponsor: The funders and the trial sponsor (University of Tasmania) had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication. These organizations did not have the right to veto publication or to control decisions regarding to which journal the manuscript was submitted.
Group Information: The OPTIMIST-A Trial Investigators appear in Supplement 4.
Data Sharing Statement: See Supplement 5.
Additional Contributions: We thank the families of infants in this study for their willingness to participate and are grateful for the assistance of staff at all sites in the conduct of the trial (Supplement 4). We thank the members of the data and safety monitoring committee for their voluntary contribution to the trial: Brian A. Darlow, MD, University of Otago, committee chair; Michael Dunn, MD, University of Toronto; and Amy Salter, PhD, The University of Adelaide. We thank the staff at the data management center at Murdoch Children’s Research Institute: Ross Dunn, BAS; Luke Stevens, BSc (salaried data managers) and the staff at the trial coordinating center at the Menzies Institute for Medical Research, University of Tasmania: Karen Butterley, RN; Nicky Stephens, MPhil; Lizzy Reid, MSc (salaried trial coordinators).