Home Usability of a Nasal Lavage System in Children

This study has been completed.
Sponsor:
Information provided by:
Aardvark Medical Company
ClinicalTrials.gov Identifier:
NCT01129765
First received: May 21, 2010
Last updated: July 27, 2010
Last verified: July 2010
Results First Received: June 2, 2010  
Study Type: Observational
Study Design: Observational Model: Case Control;   Time Perspective: Prospective
Conditions: Nasal Congestion
Respiratory Tract Infection
Sinusitis
Allergic Rhinitis
Intervention: Device: Use of an automatic nasal irrigator/aspirator

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study was performed in a pediatric ambulatory clinic in July and August of 2009. The clinical coordinator identified patients as they presented to the clinic if they met inclusion criteria and informed consent was obtained before patient entry.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Parents of Congested Children Parents of children less than six years of age with nasal congestion for which nasal suctioning and salt water irrigation is traditionally recommended.

Participant Flow:   Overall Study
    Parents of Congested Children  
STARTED     30  
COMPLETED     30  
NOT COMPLETED     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Parents of Congested Children Parents of children less than six years of age with nasal congestion for which nasal suctioning and salt water irrigation is traditionally recommended.

Baseline Measures
    Parents of Congested Children  
Number of Participants  
[units: participants]
  30  
Age  
[units: participants]
 
<=18 years     30  
Between 18 and 65 years     0  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
  0.75  ± 0.25  
Gender  
[units: participants]
 
Female     17  
Male     13  
Region of Enrollment  
[units: participants]
 
United States     30  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants Who Properly Used the Nasal Irrigator/Aspirator Device   [ Time Frame: Day one, immediately ]

2.  Secondary:   Number of Participants Who Experienced Ease of Use With the Device   [ Time Frame: Day one, immediately ]

3.  Secondary:   Number of Participants Who Found the Device to be Effective   [ Time Frame: Day one, immediately ]

4.  Secondary:   Number of Participants Who Identified the Device's User Manual as Easy to Understand   [ Time Frame: Day one, immediately ]

5.  Secondary:   Number of Patients Who Were Observed to Have an Adverse Event   [ Time Frame: Day one, immediately ]

6.  Secondary:   Number of Patients Experiencing a Physical Injury During Use   [ Time Frame: Day one, immediately ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Mary Margaret Thorne
Organization: Advanced Pediatrics
phone: 703-938-5555
e-mail: mthorne@pop.powweb.com


No publications provided


Responsible Party: Richard Schwartz, MD, Advanced Pediatrics
ClinicalTrials.gov Identifier: NCT01129765     History of Changes
Other Study ID Numbers: AM-002
Study First Received: May 21, 2010
Results First Received: June 2, 2010
Last Updated: July 27, 2010
Health Authority: United States: Institutional Review Board