Published Online: May 5, 2013. doi:10.1001/jama.2013.5555
Author Contributions: Mr Roberts had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
Study concept and design: Schmidt, Whyte, Asztalos, Moddemann, Solimano, Roberts.
Acquisition of data: All authors.
Analysis and interpretation of data: Schmidt, Whyte, Poets, Roberts.
Drafting of the manuscript: Schmidt, Roberts.
Critical revision of the manuscript for important intellectual content: Whyte, Asztalos, Moddemann, Poets, Rabi, Solimano.
Statistical analysis: Roberts.
Obtained funding: Schmidt, Whyte, Asztalos, Moddemann, Rabi.
Administrative, technical, or material support: Schmidt, Whyte, Asztalos, Moddemann, Poets, Rabi, Roberts.
Study supervision: Schmidt, Whyte, Moddemann, Poets, Rabi, Solimano, Roberts.
Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Poets reports that a local colleague received pulse oximeters for a different research study from Masimo Inc, free of charge. Dr Rabi reports that he has patents pending in the European Union and the United States for a technology that integrates with pulse oximeters to help guide oxygen use in the delivery room. Revenues will be shared with his university and health region. He also reports receiving royalties from Masimo Corporation in relation to the patent and commercialization of the technology.
The COT Trial Investigators: The following investigators, research coordinators, and hospitals participated in the Canadian Oxygen Trial. Study sites are listed according to the number of infants they enrolled. Mount Sinai Hospital, Toronto, ON, Canada: Prakesh Shah, Leanne Brown, Lisa Wenger, Samantha Frye, Francesca Imbesi, Edmond Kelly; McMaster University Medical Center, Hamilton, ON, Canada: Judy D’Ilario, Madan Roy, Barbara Schmidt, Joanne Dix, Beth Adams, Janice Cairnie, Patrice Gillie; Sunnybrook Health Sciences Center, Toronto, ON, Canada: Elizabeth Asztalos, Marilyn Hyndman, Maralyn Lacy, Denise Hohn, Laura Cooper Kurk; Pennsylvania Hospital, Philadelphia: Soraya Abbasi, Toni Mancini, Emidio Sivieri, Kathleen Finnegan; Centre Hospitalier Universitaire de Quebec, Quebec City, PQ, Canada: Aida Bairam, Sylvie Bélanger, Marianne Deschenes, Annie Fraser; The Ottawa Hospital and Children's Hospital of Eastern Ontario, Ottawa, ON, Canada: JoAnn Harrold, Jane Frank, Julie Barden; IWK Health Centre, Halifax, NS, Canada: Robin Whyte, Michael Vincer, Sharon Stone; Foothills Medical Centre and Alberta Children's Hospital, Calgary, AB, Canada: Yacov Rabi, Reg Sauve, Danielle Cyr, Heather Christianson, Deborah Anseeuw-Deeks, Dianne Creighton; Children's & Women's Health Centre of BC, Vancouver, BC, Canada: Alfonso Solimano, Lindsay Colby, Arsalan Butt, Anne Synnes, Meredith Peterson; Hospital of the University of Pennsylvania, Philadelphia, PA: Barbara Schmidt, Aasma Chaudhary, Hallam Hurt, Danielle Foy, Kristina Ziolkowski, Marsha Gerdes, Judy Bernbaum; Royal Alexandra Hospital, Edmonton, AB, Canada: Abraham Peliowski, Manoj Kumar, Leonora Hendson, Melba Athaide, Jill Tomlinson; University Children's Hospital of Tuebingen, Germany: Christian F. Poets, Dirk Bassler, Jutta Armbruster; FUNDASAMIN, Buenos Aires, Argentina: Nestor Vain, Cecilia Garcia; Maternidad Suizo: Vanesa DiGruccio, Fernanda Tamanaha; Sanatorio de la Trinidad: Noemí Jacobi; Sanatorio Otamendi: Silvia Garcia, Norma Vivas, Cristina Osio; Stony Brook University Medical Center, Stony Brook, NY: Shanthy Sridhar, Aruna Parekh, Rose McGovern; Meir Medical Center, Kfar-Saba, Israel: Shmuel Arnon, Michelle Meyer, Rachel Poller; McGill University Health Centre, Montreal, PQ, Canada: Nabeel Ali, May Khairy, Isabelle Paquet, Larissa Perepolkin, Patricia Grier, Sadia Wali; Winnipeg Health Sciences Centre, Winnipeg, MB, Canada: Mary Seshia, Diane Moddemann, John Minski, Valerie Cook, Kim Kwiatkowski, Karen A. H. Penner, Debbie Williams; Royal University Hospital, Saskatoon, SK, Canada: Laurentiu Givelichian, Koravangattu Sankaran, Cindy Thiel; Bnai Zion Medical Center, Haifa, Israel: David Bader, Bella Sandler; St. Boniface General Hospital, Winnipeg, MB, Canada: Aaron Chiu, Diane Moddemann, Dayle Everatt, Naomi Granke; Soroka University Medical Center, Beer Sheva, Israel: Agneta Golan, Esther Goldstein, Shlomith Dadoun; Oulu University Hospital, Oulu, Finland: Riitta Vikevainen, Hanna Kallankari, Tuula Kaukola, Mikko Hallman; Centre Hospitalier Universitaire Sainte-Justine, Montreal, PQ, Canada: Keith Barrington, Julie Lavoie. Steering Committee: Barbara Schmidt (Chair), Elizabeth V. Asztalos, Christian F. Poets, Yacov Rabi, Robin S. Roberts, Alfonso Solimano, Robin K Whyte. Bayley III Adjudication Committee: Diane Moddemann, Karen A. H. Penner. Data and Safety Monitoring Board: William Fraser (Chair), Deborah Davis, George Wells. Nurse Consultant: Judy D’Ilario. Neonatal Trials Group (Coordinating Center) at McMaster University, Hamilton, ON, Canada: Robin S. Roberts, Lorrie Costantini, Judy D’Ilario, Wendy Yacura, Bronwyn Gent, Harvey Nelson.
Funding/Support:Funded exclusively by the Canadian Institutes of Health Research, grant MCT-79217.
Role of the Sponsor: Neither the funding agency nor Masimo Corporation had any role in the design and conduct of the study; in the collection, analysis, and interpretation of the data; or in the preparation, review, or approval of the manuscript.