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Airway Reactivity in Children Before and After BMT Bone Marrow Transplantation

Airway Reactivity in Children Before and After Bone Marrow Transplantation

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00771836
Acronym
AHR
Enrollment
39
Registered
2008-10-15
Start date
2004-07-31
Completion date
2007-07-31
Last updated
2008-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer

Keywords

Stem cell transplantation, Airway hyper-reactivity, methacholine, pediatric

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 Children's 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 (PFT's); 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 chemo/radiotherapy. 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. PFT's 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 0.5SD 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.

Interventions

None listed

Sponsors

Rambam Health Care Campus
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
4 Years to 20 Years
Healthy volunteers
No

Inclusion criteria

* age 4.5-20 years * ability to perform spirometry consistently * FEV1\>70% predicted

Exclusion criteria

* FEV1\<70% * inability to perform methacholine challenge test before and after stem cell transplantation.

Design outcomes

Primary

MeasureTime frame
Positive MCT after SCT may be associated with increased risk of pulmonary complications3 years followup

Secondary

MeasureTime frame
The number of patients with airway reactivity increased after after SCT (p < 0.05; McNemar test).3 years followup

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026