Clinical trial NCT02082379: In-Vivo Evaluation of Nebulized Aerosols Delivered Via Nasal Route
Official title: In-Vivo Evaluation of Nebulized Aerosols Delivered Via Nasal Route
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Interface Acceptance During Delivery of Aerosol Medicine to an Infant or Child
Keywords: Interface, aerosol, child, acceptance
Lead sponsor: Arkansas Children's Hospital Research Institute
Sponsor class: OTHER
First posted: 2014-03-10
Enrollment: 21
Sex: ALL
Minimum age (years): 1
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

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 Previous unpublished data from our laboratory showed that alignment of the aerosol stream with the nostrils is very important for pulmonary deposition.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.

Eligibility 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

Primary outcomes:
measure: Acceptance of different interfaces while they receive inhaled therapy
timeFrame: within the 3 minutes of nebulization for 3 consecutive times with 5 minutes rest in between the each nebulization
Secondary outcomes:
measure: Amounts of time with the aerosol well aligned with the nostrils during transnasal aerosol delivery
timeFrame: during the 3 minutes of nebulization
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Arkansas Children's Hospital
state: Arkansas
Study officials:
affiliation: UAMS
name: Katia El Taoum, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: UAMS/ACHRI
name: Ariel Berlinski, MD
role: PRINCIPAL_INVESTIGATOR
References: