Nebulizer Intervention for Minority Children With Asthma

Asthma Clinical Trial

Official title:

Nebulizer Intervention for Minority Children With Asthma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00218816
• Other study ID #: 99-01-06-02
• Secondary ID: 5R01NR005060-04
• Status: Completed
• Phase: Phase 3
• First received: September 20, 2005
• Last updated: September 3, 2008
• Start date: August 2000
• Est. completion date: December 2005

Study information

• Verified date: September 2008
• Source: National Institute of Nursing Research (NINR)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 221
• Est. completion date: December 2005
• Est. primary completion date: December 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 8 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Asthma

Intervention

Behavioral:
• Nebulizer Education Intervention
Asthma Education
• Standard Asthma Education Groups
Asthma Education

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

References & Publications (3)

Butz AM, Donithan M, Bollinger ME, Rand C, Thompson RE. Monitoring nebulizer use in children: comparison of electronic and asthma diary data. Ann Allergy Asthma Immunol. 2005 Mar;94(3):360-5. — View Citation

Butz AM, Huss K, Mudd K, Donithan M, Rand C, Bollinger ME. Asthma management practices at home in young inner-city children. J Asthma. 2004 Jun;41(4):433-44. — View Citation

Butz AM, Syron L, Johnson B, Spaulding J, Walker M, Bollinger ME. Home-based asthma self-management education for inner city children. Public Health Nurs. 2005 May-Jun;22(3):189-99. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		12 Months	No