In-Vivo Evaluation of Nebulized Aerosols Delivered Via Nasal Route
- Conditions
- Interface Acceptance During Delivery of Aerosol Medicine to an Infant or Child
- Interventions
- Behavioral: inhaled normal saline using different interfaces.
- Registration Number
- NCT02082379
- Lead Sponsor
- 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.
- 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 Previous unpublished data from our laboratory showed that alignment of the aerosol stream with the nostrils is very important for pulmonary deposition.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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 21
- Born at term
- Healthy
- Pacifier user
- Newborn 1-6 week old
- Infants 6-8 month old
- Chronic respiratory disease
- Cardiac disease
- Prematurity
- Neurological disease
- Allergy to Normal Saline
- Allergy to any components of the interfaces
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Infants 6-8 month old 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 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. Term newborns 1-6 week old 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 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.
- Primary Outcome Measures
Name Time Method Acceptance of different interfaces while they receive inhaled therapy 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
Name Time Method Amounts of time with the aerosol well aligned with the nostrils during transnasal aerosol delivery 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
Trial Locations
- Locations (1)
Arkansas Children's Hospital
🇺🇸Little Rock, Arkansas, United States