Viewing Study NCT00218816



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Last Modification Date: 2024-10-26 @ 9:19 AM
Study NCT ID: NCT00218816
Status: COMPLETED
Last Update Posted: 2008-09-05
First Post: 2005-09-20

Brief Title: Nebulizer Intervention for Minority Children With Asthma
Sponsor: National Institute of Nursing Research NINR
Organization: National Institute of Nursing Research NINR

Study Overview

Official Title: Nebulizer Intervention for Minority Children With Asthma
Status: COMPLETED
Status Verified Date: 2008-09
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: To determine if teaching parents and children to identify the childs asthma symptoms early and if teaching the appropriate use of a nebulizer will result in a decrease in emergency department visits
Detailed 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 ie albuterol and some anti-inflammatory medications ie 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
5R01NR005060-04 NIH None httpsreporternihgovquickSearch5R01NR005060-04