In-Vivo Evaluation of Nebulized Aerosols Delivered Via Nasal Route
| Status: | Completed |
|---|---|
| Healthy: | No |
| Age Range: | Any |
| Updated: | 4/21/2016 |
| Start Date: | January 2014 |
| End Date: | February 2015 |
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.
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.
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 Previous unpublished data from our laboratory showed that alignment of the aerosol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.
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.
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
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Arkansas Children's Hospital Arkansas Children's Hospital (ACH) is the only pediatric medical center in Arkansas...
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