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In-Vivo Evaluation of Nebulized Aerosols Delivered Via Nasal Route

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ClinicalTrials.gov Identifier: NCT02082379
Recruitment Status : Completed
First Posted : March 10, 2014
Last Update Posted : January 7, 2016
Sponsor:
Information provided by (Responsible Party):
Arkansas Children's Hospital Research Institute

Brief Summary:

We hypothesize that infant and children will show different levels of acceptance of different interfaces while they receive inhaled therapy.

We also hypothesize that children will exhibit different amounts of time with the aerosol well aligned with the nostrils during transnasal aerosol delivery.


Condition or disease Intervention/treatment Phase
Interface Acceptance During Delivery of Aerosol Medicine to an Infant or Child Behavioral: inhaled normal saline using different interfaces. Not Applicable

Detailed Description:

Aerosol medicine is widely used in treating pulmonary diseases in children. Delivering drugs via aerosol faces several challenges; some are related to the drug and the delivery methods and others to the patient behavior. The latter are crucial and can significantly affect the lung deposition of the drug. Infants are known to be obligate nose breathers making the transnasal route the natural approach for drug delivery in this age group. Different interfaces are already available in the market and are specifically designed to be used in children to improve the child acceptability of the interface and by the result to improve drug deposition. Due to limitations in the use of radiolabeled aerosols and pharmacokinetics/pharmacodynamics studies in infants and children, in-vitro models were developed. These models still lack biological variability which leads to overestimating lung deposition. So, real life correction factors are needed to improve current in-vitro modeling. Previous unpublished data from our laboratory showed that alignment of the aerosol stream with the nostrils is very important for pulmonary deposition.

Our objectives are to provide real life data of acceptance of different interfaces by infants and children and to provide a real life correction factor to improve current in-vitro modeling.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: In-Vivo Evaluation of Nebulized Aerosols Delivered Via Nasal Route
Study Start Date : January 2014
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015

Arm Intervention/treatment
Active Comparator: Term newborns 1-6 week old
A Hudson nebulizer will be loaded with 3 mls of normal saline and operated at 7 L/min of wall air for 3 minutes with each scenario with a 5-minute interval between interfaces. The interfaces that will be used are: tight mask, the angled PediNeb, the B&B adapter, mask placed at 2 cm from the face, the PediNeb T-piece, and a capped corrugated tubing placed 2 cm away from the face.
Behavioral: inhaled normal saline using different interfaces.
A Hudson nebulizer will be loaded with 3 mls of normal saline and operated at 7 L/min of wall air for 3 minutes with each scenario with a 5-minute interval between interfaces. The infants will be videotape while they receive inhaled aerosol, and sound will be captured. The camera will be positioned so the face of the parent holding the child will not be visible.

Active Comparator: Infants 6-8 month old
A Hudson nebulizer will be loaded with 3 mls of normal saline and operated at 7 L/min of wall air for 3 minutes with each scenario with a 5-minute interval between interfaces. The interfaces that will be used are: tight mask, the angled PediNeb, the B&B adapter, mask placed at 2 cm from the face, the PediNeb T-piece, and a capped corrugated tubing placed 2 cm away from the face.
Behavioral: inhaled normal saline using different interfaces.
A Hudson nebulizer will be loaded with 3 mls of normal saline and operated at 7 L/min of wall air for 3 minutes with each scenario with a 5-minute interval between interfaces. The infants will be videotape while they receive inhaled aerosol, and sound will be captured. The camera will be positioned so the face of the parent holding the child will not be visible.




Primary Outcome Measures :
  1. Acceptance of different interfaces while they receive inhaled therapy [ Time Frame: within the 3 minutes of nebulization for 3 consecutive times with 5 minutes rest in between the each nebulization ]
    The recordings will be analyzed by the 2 investigators for acceptance of the patient of the interface (likert scale 1 to 5: 5= Complete acceptance, 4= Accepting most of the time, 3= Accepting/rejecting half of the time, 2= Rejecting most of the time, 1= Complete rejection). The data will be expressed as average of value assigned by each of the 2 researchers. Analysis of variance for repeated measures followed by Tukey test will be used to compare the 2 endpoints. A p value < 0.05 will be considered statistically significant


Secondary Outcome Measures :
  1. Amounts of time with the aerosol well aligned with the nostrils during transnasal aerosol delivery [ Time Frame: during the 3 minutes of nebulization ]
    The recordings will be analyzed by the 2 investigators for percentage of time spent with aerosol aligned with the patient nostrils when using different interfaces



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Ages Eligible for Study:   up to 8 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Born at term
  • Healthy
  • Pacifier user
  • Newborn 1-6 week old
  • Infants 6-8 month old

Exclusion Criteria:

  • Chronic respiratory disease
  • Cardiac disease
  • Prematurity
  • Neurological disease
  • Allergy to Normal Saline
  • Allergy to any components of the interfaces

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02082379


Locations
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United States, Arkansas
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202
Sponsors and Collaborators
Arkansas Children's Hospital Research Institute
Investigators
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Principal Investigator: Katia El Taoum, MD UAMS
Principal Investigator: Ariel Berlinski, MD UAMS/ACHRI
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Responsible Party: Arkansas Children's Hospital Research Institute
ClinicalTrials.gov Identifier: NCT02082379    
Other Study ID Numbers: 202438
First Posted: March 10, 2014    Key Record Dates
Last Update Posted: January 7, 2016
Last Verified: January 2016
Keywords provided by Arkansas Children's Hospital Research Institute:
Interface, aerosol, child, acceptance