Bronchiolitis Obliterans Clinical Trial
— RESPPEDHEMOfficial title:
Prospective Study of Late Pulmonary Complications Occurring in Children Treated With Allogeneic Hematopoietic Stem Cells.
Verified date | April 2020 |
Source | Assistance Publique - Hôpitaux de Paris |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Hematopoietic stem cell transplantation (HSCT) is used to treat an expanding array of malignant and non-malignant disorders. This is a prospective multicenter study, in pediatric allo-BMT recipients to analyze the spectrum of noninfectious pulmonary complications (PC), to evaluate the prevalence and course of PFT abnormalities before and after transplant, and to detect risk factor for PC.
Status | Completed |
Enrollment | 300 |
Est. completion date | March 30, 2020 |
Est. primary completion date | March 30, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 18 Years |
Eligibility |
Inclusion Criteria: - Age: from birth to 18 years - Patient to be treated by allogeneic hematopoietic stem cell - Parents who have given their signed consent for the study - Affiliation to a social security scheme Exclusion Criteria: - non exclusion criteria |
Country | Name | City | State |
---|---|---|---|
France | Houdouin véronique | Paris |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Presence of belated non-infectious pulmonary complications | 3 years | ||
Secondary | Presence of risk factors for belated non-infectious pulmonary complications | 3 years | ||
Secondary | Survival three years | 3 years | ||
Secondary | Severity of respiratory disease | 3 years |
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