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In-Vivo Evaluation of Nebulized Aerosols Delivered Via Nasal Route

NCT02082379 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2016-01-07

No results posted yet for this study

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.

Conditions

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

Interventions

BEHAVIORAL

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.

Sponsors & Collaborators

  • Arkansas Children's Hospital Research Institute

    lead OTHER

Principal Investigators

  • Katia El Taoum, MD · UAMS

  • Ariel Berlinski, MD · UAMS/ACHRI

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Week
Max Age
8 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2015-02-28
Completion
2015-02-28

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02082379 on ClinicalTrials.gov