Pulmonary Function at Presentation and Follow-up in Hemato-Oncology 3-7 Years Old Children

Pulmonary Function at Presentation and Follow-up in Hemato-Oncology 3-7 Years

The aim of this study was to investigate the occurrences of respiratory symptoms risk factors and abnormalities in lung function in young children (3-6 years old) with hemato-oncologic diseases at presentation (before treatment) and up to 3 years follow-up (study period).

Study Overview

• Status: Completed
• Conditions: Acute Lymphoblastic Leukemia; Hodgkin's Disease; Acute Myeloblastic Leukemia; Solid Tumors,; Non-Malignant

Detailed Description

Pulmonary function tests (PFTs) are a part of the routine follow-up of patients receiving anti-cancer treatment. Treatment is frequently associated with diverse pulmonary damage which may become functionally and clinically evident many years later. PFTs may help to quantify the damage in the lungs; help to evaluate the point at which lung function deviates from normal to allow early intervention before irreversible lung damage occurs and thereby to reduce morbidity and mortality.

Reliable PFTs in the preschool age have traditionally been difficult to perform, but recent publications have demonstrated that the majority of preschool children can produce reproducible forced expiratory flow volume (FEVC) curves with proper coaching techniques. This recent development may enable studying the long term effect (years) of treatment on lung function in young children suffering from hemato-oncologic diseases.

• Study Type: Observational
• Enrollment (Actual): 35

Contacts and Locations

Study Locations

• Israel
  • Ramat Gan
    • Ramat-Gan, Ramat Gan, Israel, 52621
      • Sheba Medical CenterPediatric pulmonary unit, Pulmonary function laboratory

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 7 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All pediatric patients (age 3-7 years) with hemato-onclogic diseases that were treated at the Hemato-Oncology Department, and were sent to the pediatric pulmonary unit at the Safra children's hospital, Sheba medical center, Ramat-Gan, Israel, to perform lung function tests, as a part of a 3-year follow-up study.

Description

Inclusion Criteria:

• All pediatric patients (age 3-7 years) with hemato-onclogic diseases that were treated at the Hemato-Oncology Department, and were sent to the pediatric pulmonary unit.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
1; all were in a single group

Collaborators and Investigators

• Sponsor: Sheba Medical Center
• Investigators: Principal Investigator: Ori Efrati, MD, Sheba Medical Center

Study record dates

Study Major Dates

• Study Start: October 1, 2005
• Study Completion (Actual): October 1, 2006

Study Registration Dates

• First Submitted: November 1, 2007
• First Submitted That Met QC Criteria: November 1, 2007
• First Posted (Estimate): November 2, 2007

Study Record Updates

• Last Update Posted (Estimate): November 2, 2007
• Last Update Submitted That Met QC Criteria: November 1, 2007
• Last Verified: November 1, 2007

More Information

Terms related to this study

• Keywords: acute lymphoblastic leukemia; long-term lung function
• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma; Leukemia, Myeloid; Leukemia; Leukemia, Myeloid, Acute; Hodgkin Disease; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid
• Other Study ID Numbers: SHEBA-05-3889-OE-CTIL; Observational