A phase II, multicenter, nonblinded, randomized controlled trial for evaluating protective effects of ABPC/SBT plus, azithromycin versus erythromycin, in pregnant women with pPROM occurring at <28 weeks of gestation on the development of BPD in neonates: Study protocol

• Akihide Ohkuchi ,

  Roles Conceptualization, Funding acquisition, Investigation, Methodology, Project administration, Resources, Writing – original draft, Writing – review & editing

  * E-mail: okuchi@jichi.ac.jp

  Affiliation Maternal and Fetal Neonatal Intensive Care Unit, Jichi Medical University Hospital, Tochigi, Japan

  https://orcid.org/0000-0002-8861-1572

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• Kaoru Okazaki,

  Roles Conceptualization, Investigation, Methodology, Writing – review & editing

  Affiliation Department of Neonatology, Tokyo Metropolitan Children’s Medical Center, Fuchu-shi, Tokyo, Japan

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• Shintaro Iwamoto,

  Roles Formal analysis

  Affiliation Division of Biostatistics, Department of Data Science, Clinical Research Center, National Center for Child Health and Development, Setagaya-ku, Tokyo, Japan

  https://orcid.org/0000-0001-9266-7811

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• Mayumi Sako,

  Roles Conceptualization, Methodology, Project administration, Supervision, Writing – review & editing

  Affiliation Department of Clinical Research Promotion, Clinical Research Center, National Center for Child Health and Development, Setagaya-ku, Tokyo, Japan

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• Tohru Kobayashi,

  Roles Conceptualization, Methodology, Project administration, Supervision, Writing – review & editing

  Affiliation Department of Data Science, Clinical Research Center, National Center for Child Health and Development, Setagaya-ku, Tokyo, Japan

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• Itaru Yanagihara,

  Roles Conceptualization, Investigation, Methodology, Resources, Writing – review & editing

  Affiliation Department of Developmental Medicine, Research Institute, Osaka Women’s and Children’s Hospital, Izumi-shi, Osaka, Japan

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• Makoto Nomiyama,

  Roles Conceptualization, Investigation, Methodology, Writing – review & editing

  Affiliation Department of Obstetrics and Gynecology, National Hospital Organization Saga Hospital, Saga-shi, Saga, Japan

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• on behalf of the group of the PPROM-AZM study

  ¶Membership of the group of the PPROM-AZM study is listed in the Acknowledgments.

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