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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

November 1, 2007

Last Updated Date

November 1, 2007

Start Date ^†

October 2005

Current Primary Outcome Measures ^†

Original Primary Outcome Measures ^†

Change History

No Changes Posted

Current Secondary Outcome Measures ^†

Original Secondary Outcome Measures ^†

Descriptive Information

Brief Title ^†

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

Official Title ^†

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

Brief Summary

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).

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 Phase

Study Type ^†

Observational

Study Design ^†

Cohort, Retrospective

Condition ^†

Acute Lymphoblastic Leukemia
Acute Myeloblastic Leukemia
Solid Tumors,
Hodgkin's Disease
Non-Malignant

Intervention ^†

Study Arms / Comparison Groups

all were in a single group

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

Completion Date

October 2006

Primary Completion Date

Eligibility Criteria ^†

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.

Gender

Both

Ages

3 Years to 7 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Israel

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00552825

Responsible Party

Secondary IDs ^††

Observational

Study Sponsor ^†

Sheba Medical Center

Collaborators ^††

Investigators ^†

Principal Investigator:

Ori Efrati, MD

Sheba Medical Center

Information Provided By

Sheba Medical Center

Verification Date

November 2007

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.