JMIR Publications

ABSTRACT

Introduction: Because of the improvements in survival rates for preterm infants, not only the rates of bronchopulmonary dysplasia (BPD) but also that of long-term respiratory complications of premature birth are increasing, which results in financial and health burdens in developed countries. Thus far, risk factors of respiratory morbidities of extremely preterm infants remain unknown. Furthermore, the definition, as well as the predictive ability, of BPD for long-term respiratory outcomes are yet to be determined. Therefore, Extreme Prematurity and Pulmonary Outcomes Program in Saitama (EPOPS) aims to develop the diagnostic criteria for BPD and to determine the prognostic factors contributing to the long-term pulmonary outcomes manifested in extremely preterm infants. Methods and analysis: The EPOPS is an observational prospective cohort study performed by a consortium of six neonatal intensive care units (NICUs) in Saitama, Japan. The subjects included in this study were infants (from each clinical center) with gestational ages 22 to 27 weeks, having an expected target of 400 subjects. This study aims to determine the definition of BPD and other perinatal factors which accurately predict the long-term pulmonary outcomes in survivors of extreme prematurity. Moreover, association between BPD and post-prematurity respiratory disease (PRD) will also be investigated using generalized linear models. Discussion: The EPOPS incorporates the aspects of neonatal care in secondary- and tertiary-level NICUs to develop the existing research studies on the definition of BPD, objective biomarkers, and outcome measures of respiratory morbidity in extremely preterm infants beyond the NICU hospitalization, thereby leading to a novel understanding of the nature and natural history of BPD and of potential mechanistic and therapeutic targets among at-risk subjects. Ethics and Dissemination: The protocol and consent forms were evaluated and approved by institutional review boards at each EPOPS center. Registration details: Not registered because of an observational study without any interventions.