Ignite Creation Date:
2024-05-05 @ 7:57 PM
Last Modification Date:
2024-10-26 @ 9:56 AM
Study NCT ID:
NCT00771836
Status:
COMPLETED
Last Update Posted:
2008-10-15
First Post:
2008-05-27
Brief Title:
Airway Reactivity in Children Before and After BMT Bone Marrow Transplantation
Sponsor:
Rambam Health Care Campus
Organization:
Rambam Health Care Campus
Study Overview
Official Title:
Airway Reactivity in Children Before and After Bone Marrow Transplantation
Status:
COMPLETED
Status Verified Date:
2008-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AHR
Brief Summary:
Background Stem cell transplantation SCT is associated with pulmonary complications and may lead to high morbidity and mortality We encountered several children post-SCT with a clinical picture suggestive of airway hyper-reactivity AHR and evidence of reversible airway obstruction that was not reported pre-transplant Our aim was to determine if SCT induced AHR as assessed by methacholine challenge test MCT and to determine any correlation between AHR and pulmonary complications
Methods Prospective study evaluating consecutive patients referred for SCT to the Department of Pediatric Hemato-Oncology at Meyer Childrens Hospital Evaluation included pulmonary function test and methacholine challenge test before and after the transplantation and assessment of pulmonary complications
Methods Prospective study evaluating consecutive patients referred for SCT to the Department of Pediatric Hemato-Oncology at Meyer Childrens Hospital Evaluation included pulmonary function test and methacholine challenge test before and after the transplantation and assessment of pulmonary complications
Detailed Description:
We encountered several children post SCT with clinical picture suggestive of airway hyper-reactivity AHR by spirometric evidence of reversible airway obstruction that was not reported pre transplantation Our question was if AHR is present but undiagnosed pre BMT or AHR is developed post transplantation
Our aim was to determine if BMT induces AHR as assessed by methacholine challenge test MCT and to determine a possible correlation between AHR and pulmonary complications The study was Prospective Subjects consecutive patients were referred for pulmonary function tests PFTs MCT and clincical evaluation before SCT and were followed after transplantation for at least a year The study was approved by the ethics committee and parental consent was obtained Clnical evaluation included medical history type of disease previous chemoradiotherapy Type of SCT was recorded allogeneic autologous respiratory evaluation included Respiratory history previous asthma medications allergy parental smoking Physical exam CXR O2-Sat on rest and exercise PFTs included Spirometry lung volumes diffusion capacity MCT prior and 2-6 months post SCT Follow-up 6-12 months post SCT Pulmonary complication Any respiratory symptoms or signs cough SOB hemoptysis hypoxemia New chest radiological finding Number of hospitalizations due to pulmonary complications
Statistics Sample size-26 patients to detect an increase of 05SD in AHR with a power of 80 No of children with AHR before and after SCT Pulmonary complications and AHR hospitalizations for pulmonary complications and AHR
Our aim was to determine if BMT induces AHR as assessed by methacholine challenge test MCT and to determine a possible correlation between AHR and pulmonary complications The study was Prospective Subjects consecutive patients were referred for pulmonary function tests PFTs MCT and clincical evaluation before SCT and were followed after transplantation for at least a year The study was approved by the ethics committee and parental consent was obtained Clnical evaluation included medical history type of disease previous chemoradiotherapy Type of SCT was recorded allogeneic autologous respiratory evaluation included Respiratory history previous asthma medications allergy parental smoking Physical exam CXR O2-Sat on rest and exercise PFTs included Spirometry lung volumes diffusion capacity MCT prior and 2-6 months post SCT Follow-up 6-12 months post SCT Pulmonary complication Any respiratory symptoms or signs cough SOB hemoptysis hypoxemia New chest radiological finding Number of hospitalizations due to pulmonary complications
Statistics Sample size-26 patients to detect an increase of 05SD in AHR with a power of 80 No of children with AHR before and after SCT Pulmonary complications and AHR hospitalizations for pulmonary complications and AHR
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| AHRBMT1866 | None | None | None |