| Item | Content |
|---|---|
| Research project name | Research Project on the Rare / Intractable Disease |
| Study title | Study on preparation of practice guidelines and establishment and dissemination of the medical system for congenital respiratory and thoracic dysplasia |
| Name of principal investigator | Noriaki Usui |
| Name of institution of the principal investigator | Department of Pediatric Surgery, Osaka Women's and Children's Hospital |
| Target disease | Congenital diaphragmatic hernia |
| Registry name | Survey on the actual status of neonatal diaphragmatic hernia |
| Purpose of registry | Survey of natural history, Investigation into the number or the distribution of patients, Epidemiological study, Others (study on development of AMED evidence and collaboration) |
| Overview of registry | Study design: multicenter prospective cohort study Study objectives: 1) To understand the latest status of CDH treatment in high volume centers in Japan. 2) To clarify the reality of short- and long-term outcome. 3) To prepare classification of severity based on prognostic factor analysis, and ultimately, 4) To prepare the treatment guidelines and standard protocol by degree of severity to improve short- and long-term prognoses of congenital diaphragmatic hernia.The primary outcome is defined as 90-day survival rate, and secondary outcome and prognostic factors will be investigated. Subjects: All neonates who were diagnosed with congenital diaphragmatic hernia at the participating institutions among the neonates who were born between January 1, 2011 and December 31, 2020 are included as the subjects. Patients will not be excluded by presence of prenatal diagnosis, presence of serious associated anomalies (e.g., chromosome abnorlmality, serious cardiac disease), and selection of treatment (active, palliative or restrictive). Methods: Persons in charge at each institution will register cases based on the medical record of all subject neonates, tabulate the data, and investigate CDH treatment outcome. |
| Research item | Sex, Date of birth, Information about the current medical institutions of patients, Complication, History of present illness, History of treatment, Degree of severity, Clinical course, Functional prognosis, Prognosis, Cause of death |
| Contact | Hiroomi Okuyama |
| E-mail address | okuyama●pedsurg.med.osaka-u.ac.jp |
| Registry URL | https://rdc01.dcc.med.osaka-u.ac.jp/redcap/ |
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