In-Vivo Evaluation of Nebulized Aerosols Delivered Via Nasal Route
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 21
- Locations
- 2
- Primary Endpoint
- Acceptance of different interfaces while they receive inhaled therapy
Study Overview
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.
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 Previous unpublished data from our laboratory showed that alignment of the aerosol stream with the nostrils is very important for pulmonary deposition.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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Masking
- None
Eligibility Criteria
- Ages
- 1 Week to 8 Months (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Born at term
- •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
Outcomes
Primary Outcomes
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 Outcomes
- Amounts of time with the aerosol well aligned with the nostrils during transnasal aerosol delivery(during the 3 minutes of nebulization)