In-Vivo Evaluation of Nebulized Aerosols Delivered Via Nasal Route

NCT ID: NCT02082379

Last Updated: 2016-01-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2015-02-28

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 Previous unpublished data from our laboratory showed that alignment of the aerosol stream with the nostrils is very important for pulmonary deposition.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

Conditions

Interface Acceptance During Delivery of Aerosol Medicine to an Infant or Child

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

inhaled normal saline using different interfaces.

Intervention Type: BEHAVIORAL

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.

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.

Group Type: ACTIVE_COMPARATOR

inhaled normal saline using different interfaces.

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 1 Week
• Maximum Eligible Age: 8 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Arkansas Children's Hospital Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Katia El Taoum, MD

Role: PRINCIPAL_INVESTIGATOR

UAMS

Ariel Berlinski, MD

Role: PRINCIPAL_INVESTIGATOR

UAMS/ACHRI

Locations

Arkansas Children's Hospital

Little Rock, Arkansas, United States

Countries

United States

Other Identifiers

202438

Identifier Type: -

Identifier Source: org_study_id