Phase 4
N=96
A Comparative Evaluation of the Performance and Fit of Pediatric Face Masks
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT02224612 ↗Enrolled (actual)
96
Serious AEs
0.0%
Results posted
Apr 2019
Primary outcome: Primary: Change From Baseline in Carbon Dioxide Levels — -0.07; -0.79 mmHg
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Medline Pediatric Face Masks (Device); KC Childs Mask (Device)
- Age
- Pediatric · 4+ yrs
- Sex
- All
- Sponsor
- Medline Industries
- Primary completion
- Jan 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Carbon Dioxide Levels |
-0.07; -0.79 | — |
| SECONDARY Physical Fit of Pediatric Face Masks. |
.80; .31 | — |
Summary
Compare the fit of two pediatric face masks in children.
Eligibility Criteria
Inclusion Criteria
- 4 to 12 years of age
- conscious
Exclusion Criteria
- able to wear a mask
- no previous allergic reactions to face masks
Data sourced from ClinicalTrials.gov (NCT02224612). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.