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Sponsored by: |
National Institute of Nursing Research (NINR) |
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Information provided by: | National Institute of Nursing Research (NINR) |
ClinicalTrials.gov Identifier: | NCT00218816 |
To determine if teaching parents and children to identify the child's asthma symptoms early and if teaching the appropriate use of a nebulizer will result in a decrease in emergency department visits.
Condition | Intervention | Phase |
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Asthma |
Behavioral: Nebulizer Education Intervention Behavioral: Standard Asthma Education Groups |
Phase III |
Study Type: | Interventional |
Study Design: | Randomized, Open Label, Uncontrolled, Parallel Assignment |
Official Title: | Nebulizer Intervention for Minority Children With Asthma |
Enrollment: | 221 |
Study Start Date: | August 2000 |
Study Completion Date: | December 2005 |
Primary Completion Date: | December 2005 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Behavioral: Nebulizer Education Intervention
Asthma Education
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2 |
Behavioral: Standard Asthma Education Groups
Asthma Education
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Nebulizer use in young children is common with prevalence of 33-71% in children under age 12 years. Nebulizers are used primarily to administer SABA medications, (i.e., albuterol) and some anti-inflammatory medications (i.e., budesonide, cromolyn). Parents may prefer nebulizer delivery due to the inability of young children to coordinate respiration with aerosol delivery and many parents lack confidence in administering metered-dose inhaler (MDI) medications to young children. Physician preference for nebulizer administration of asthma medications is low, but is favored due to direct medication delivery to the respiratory system despite studies indicating MDIs with spacers are as effective as nebulizers in delivering asthma medications to young children.
Although national guidelines recommend a nebulizer with mask for children 2 years or younger most asthma educational programs lack specific content addressing appropriate nebulizer technique including when and what symptoms to treat at home, optimal length of a nebulized medication session, prevention of SABA overuse and appropriate cleaning and maintenance of the device. Because the overuse of home nebulizer SABA medications has been associated with fatal asthma, instruction and supervision of nebulized rescue medication delivery in addition to appropriate preventive medication use may reduce asthma morbidity and mortality .
The current study was conducted to determine the effectiveness of a home-based nebulizer educational intervention (NEI) for young children with asthma. The intervention was designed to teach early symptom recognition, appropriate medication use and nebulizer technique for home treatment of acute asthma episodes. Study outcomes included symptom frequency, activity limitation, emergency department (ED) visits and hospitalizations, appropriate asthma medication use and nebulizer practice. We hypothesized that children receiving the NEI would demonstrate improvement in appropriate nebulizer and asthma medication use and decreased asthma symptoms, activity limitation, ED visits and hospitalizations.
Ages Eligible for Study: | 2 Years to 8 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Johns Hopkins University School of Medicine Department of Pediatrics ( Arlene Butz, ScD, RN, MSN, Professor ) |
Study ID Numbers: | 99-01-06-02, 5R01NR005060-04 |
Study First Received: | September 20, 2005 |
Last Updated: | September 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00218816 History of Changes |
Health Authority: | United States: Federal Government |
Hypersensitivity Lung Diseases, Obstructive Respiratory Tract Diseases Bronchial Diseases |
Lung Diseases Hypersensitivity, Immediate Asthma Respiratory Hypersensitivity |
Hypersensitivity Lung Diseases, Obstructive Immune System Diseases Respiratory Tract Diseases Bronchial Diseases |
Lung Diseases Hypersensitivity, Immediate Asthma Respiratory Hypersensitivity |