Abstract
BackgroundBecause of the improvements in survival rates for preterm infants, not only the rates of bronchopulmonary dysplasia (BPD) but also those of long-term respiratory complications of premature birth are increasing, resulting in financial and health burdens in developed countries. Thus far, the risk factors of respiratory morbidities in extremely preterm infants remain unknown. Furthermore, the definition and the predictive ability of BPD for long-term respiratory outcomes are yet to be determined.ObjectiveThe objective of our study, Extreme Prematurity and Pulmonary Outcomes Program in Saitama, is to develop the diagnostic criteria for BPD and to determine the prognostic factors contributing to the long-term pulmonary outcomes manifesting in extremely preterm infants.MethodsThe Extreme Prematurity and Pulmonary Outcomes Program in Saitama 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 are infants (from each clinical center) with gestational ages 22 to 27 weeks. The target is 400 subjects. This study aims to determine the definition of BPD and other perinatal factors that accurately predict the long-term pulmonary outcomes in survivors of extreme prematurity. Moreover, the association between BPD and postprematurity respiratory disease will be investigated using generalized linear models.ResultsThe protocol and consent forms were evaluated and approved on September 5, 2019, by the Ethics Committee of Saitama Medical Center, Saitama Medical University. Enrollment began on April 1, 2020. It is expected to end on March 31, 2023. The follow-up for 1 year corrected age is expected to continue through the middle of 2024.ConclusionsThe Extreme Prematurity and Pulmonary Outcomes Program in Saitama incorporates aspects of neonatal care in secondary- and tertiary-level NICUs to develop existing research studies on the definition of BPD, objective biomarkers, and outcome measures of respiratory morbidity in extremely preterm infants beyond NICU hospitalization, thereby leading to a novel understanding of the nature and natural history of BPD and potential mechanistic and therapeutic targets in at-risk subjects.International Registered Report Identifier (IRRID)DERR1-10.2196/22948
Highlights
The rate of preterm birth has been increasing over the past several decades [1]
This study aims to determine the definition of bronchopulmonary dysplasia (BPD) and other perinatal factors that accurately predict the long-term pulmonary outcomes in survivors of extreme prematurity
We created the Extreme Prematurity and Pulmonary Outcomes Program in Saitama to determine the diagnostic criteria for BPD and the prognostic factors contributing to the 1-year respiratory morbidity in a cohort of more than 400 extremely preterm infants
Summary
The rate of preterm birth has been increasing over the past several decades [1]. Preterm birth is associated with serious respiratory diseases, such as bronchopulmonary dysplasia (BPD), which can be problematic during the first 2 years of life and even in the teen and adult years [2]. Considering the gaps in definitional, operational, and mechanistic understanding, Maitre et al created the Prematurity and Respiratory Outcomes Program (PROP), a prospective multicenter study of respiratory outcomes among preterm infants in the United States, with the goal to determine the characteristics of persistent pulmonary diseases associated with prematurity and develop the means of predicting the risk factors of the disease [3,4] They concluded that both BPD and perinatal clinical data, including male sex, smoking during pregnancy, infant race, public insurance, birth weight, and parent with asthma, accurately determined extremely preterm infants at risk for persistent and severe respiratory morbidity at 1 year [5]. The definition and the predictive ability of BPD for long-term respiratory outcomes are yet to be determined
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