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Extreme Prematurity and Pulmonary Outcomes Program in Saitama: Protocol for a Prospective Multicenter Cohort Study in
Fumihiko Namba1, Kosuke Tanaka1, Sayu Omori2
1Department of Pediatrics, Saitama Medical Center, Saitama Medical University, Saitama, Japan.
Insights
This study aims to define bronchopulmonary dysplasia (BPD) and identify risk factors for long-term respiratory issues in extremely preterm infants. Understanding these factors is crucial for improving outcomes and reducing health burdens.
Area of Science:
- Neonatal Medicine
- Pediatric Pulmonology
- Clinical Research
Background:
- Increasing survival rates of preterm infants have led to rising rates of bronchopulmonary dysplasia (BPD) and long-term respiratory complications.
- Significant financial and health burdens are associated with these conditions in developed countries.
- Risk factors and predictive definitions for BPD in extremely preterm infants remain largely unknown.
Purpose of the Study:
- To establish diagnostic criteria for BPD in extremely preterm infants.
- To identify prognostic factors influencing long-term pulmonary outcomes.
- To investigate the association between BPD and postprematurity respiratory disease.
Main Methods:
- An observational prospective cohort study involving six neonatal intensive care units (NICUs) in Saitama, Japan.
- Enrollment of 400 infants with gestational ages between 22 and 27 weeks.
- Utilizing generalized linear models to analyze the association between BPD and respiratory outcomes.
Main Results:
- Protocol and consent forms approved September 5, 2019.
- Enrollment commenced April 1, 2020, with an expected end date of March 31, 2023.
- One-year corrected age follow-up anticipated through mid-2024.
Conclusions:
- The program integrates neonatal care from multiple NICUs to advance research on BPD definition and biomarkers.
- Aims to provide a novel understanding of BPD's nature and natural history in extremely preterm infants.
- Seeks to identify potential mechanistic and therapeutic targets for at-risk infants.
Background:
Because 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.
Objective:
The 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.
Methods:
The 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.
Results:
The 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.
Conclusions:
The 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.
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