NCT01131663

Brief Summary

Face masks are used for many respiratory care applications such as anaesthesia, resuscitation, and aerosol therapy. None of the currently available face mask for infants and young children are specifically designed and developed for infants. The aim of this study is to design, develop and test the first infant's oriented face mask. To achieve this ultimate goal we will first define appropriate sizes of infants' faces that would be used as templates for the design and development of optimally fitted model masks. In the next stage we will use these masks and incorporate the infants' own soother (pacifier) into a new SootherMask (SM). In the last part of the study we will compare acceptance levels between Soothermask (SM) and a conventional commodity masks without a pacifier.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2010

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 25, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 27, 2010

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

May 27, 2010

Status Verified

May 1, 2010

Enrollment Period

1 year

First QC Date

May 25, 2010

Last Update Submit

May 25, 2010

Conditions

Infant

Keywords

Infants, aerosol, acceptance, face mask, drug delivery

Outcome Measures

Primary Outcomes (1)

  • Acceptance levels of new infant face mask

    Infants will be offered two sets of simulated treatment options at random order: Placebo treatment by nebulizer (half the group) or by Valved Holding Chamber (VHC) (the other half) through the SM followed by placebo treatment by nebulizer (half the group) or by VHC (the other half) through the conventional mask. Treatments will be done sequentially at random order while the procedure is being captured and recorded on video. The video clips will be analyzed later off site and will be coded according to the scale in the scoring form to compare between acceptance levels of the two face masks.

    10 minutes

Eligibility Criteria

AgeUp to 4 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

hospitals,primary care clinic, community sample

You may qualify if:

  • Signed informed consent

You may not qualify if:

  • Non cooperation with procedure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ziv Medical center

Safed, 13100, Israel

RECRUITING

Pediatric Department, Ziv Medical Center

Safed, Israel

RECRUITING

Study Officials

  • Israel Amirav, MD

    Ziv Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Israel Amirav, MD

CONTACT

97246828712amirav@012.net.il

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

May 25, 2010

First Posted

May 27, 2010

Study Start

April 1, 2010

Primary Completion

April 1, 2011

Study Completion

April 1, 2012

Last Updated

May 27, 2010

Record last verified: 2010-05

Locations

IL(2)