Airway Reactivity in Children Before and After BMT Bone Marrow Transplantation (AHR)

Airway Reactivity in Children Before and After Bone Marrow Transplantation

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.

Study Overview

• Status: Completed
• Conditions: Cancer

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.

• Study Type: Observational
• Enrollment (Actual): 39

Contacts and Locations

Study Locations

• Israel
  • Haifa, Israel
    • Pediatric Pulmonary Unit, Meyer Children's Hospital of Haifa, Meyer Children's Hospital, Rambam Medical Center, and the Bruce Rappaport Faculty of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 20 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Children who underwent SCT in the Department of Pediatric Hemato-Oncology at Meyer Children's Hospital and were referred to the Pediatric Pulmonary Unit.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Positive MCT after SCT may be associated with increased risk of pulmonary complications	3 years followup

Secondary Outcome Measures

Outcome Measure	Time Frame
The number of patients with airway reactivity increased after after SCT (p < 0.05; McNemar test).	3 years followup

Collaborators and Investigators

• Sponsor: Rambam Health Care Campus

Study record dates

Study Major Dates

• Study Start: July 1, 2004
• Primary Completion (Actual): July 1, 2007
• Study Completion (Actual): July 1, 2007

Study Registration Dates

• First Submitted: May 27, 2008
• First Submitted That Met QC Criteria: October 14, 2008
• First Posted (Estimate): October 15, 2008

Study Record Updates

• Last Update Posted (Estimate): October 15, 2008
• Last Update Submitted That Met QC Criteria: October 14, 2008
• Last Verified: October 1, 2008

More Information

Terms related to this study

• Keywords: pediatric; Stem cell transplantation; methacholine; Airway hyper-reactivity
• Other Study ID Numbers: RambamMC1866CTIL; AHRBMT1866