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OpenTrials
Completed

NCT Number: NCT00218816

Nebulizer Intervention for Minority Children With Asthma

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.

Completed

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Key information

Age range

2 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Johns Hopkins University

Baltimore, Maryland, 21287, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Physician diagnosed asthma, use of nebulizer in past 30 days, wheezing or cough symptoms at least weekly during the past 30 days.

Exclusion criteria

  • Participation in another asthma study or having other respiratory illness such as cystic fibrosis, BPD

Treatment and study plan

Nebulizer Education Intervention

Behavioral

Asthma Education

Standard Asthma Education Groups

Behavioral

Asthma Education

Primary outcomes

  1. 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.

    Time frame: 12 Months

Sponsors and collaborators

Lead sponsor

National Institute of Nursing Research (NINR)

Nih

Registry information

Important dates

Study start
2000
Primary completion
2005
Study completion
2005
First posted
Sep 22, 2005
Registry last updated
Sep 5, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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