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Nebulizer Intervention for Minority Children With Asthma

NCT ID: NCT00218816

Last Updated: 2008-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

221 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-08-31

Study Completion Date

2005-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

Nebulizer Education Intervention

Intervention Type BEHAVIORAL

Asthma Education

2

Group Type OTHER

Standard Asthma Education Groups

Intervention Type BEHAVIORAL

Asthma Education

Interventions

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Nebulizer Education Intervention

Asthma Education

Intervention Type BEHAVIORAL

Standard Asthma Education Groups

Asthma Education

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

2 Years

Maximum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Nursing Research (NINR)

NIH

Sponsor Role lead

Responsible Party

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Johns Hopkins University School of Medicine Department of Pediatrics

Principal Investigators

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Arlene M Butz, SCD,MSN,BSN

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

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Johns Hopkins University

Baltimore, Maryland, United States

Site Status

Countries

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United States

References

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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. doi: 10.1081/jas-120033985.

Reference Type BACKGROUND
PMID: 15281329 (View on PubMed)

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. doi: 10.1016/S1081-1206(10)60988-X.

Reference Type BACKGROUND
PMID: 15801247 (View on PubMed)

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. doi: 10.1111/j.0737-1209.2005.220302.x.

Reference Type BACKGROUND
PMID: 15982192 (View on PubMed)

Other Identifiers

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5R01NR005060-04

Identifier Type: NIH

Identifier Source: secondary_id

View Link

99-01-06-02

Identifier Type: -

Identifier Source: org_study_id