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Design and Development of an Infant's Oriented Face Mask

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ClinicalTrials.gov Identifier: NCT01131663
Recruitment Status : Unknown
Verified May 2010 by Ziv Hospital.
Recruitment status was:  Recruiting
First Posted : May 27, 2010
Last Update Posted : May 27, 2010
Information provided by:
Ziv Hospital

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.

Condition or disease

Detailed Description:

Not all face masks are "born equal" and care must be taken in mask design, particularly for the early pediatric age group. Unfortunately, facemasks provided for infants and young children have been merely smaller versions of those used for adults with little consideration given to their special needs

We believe that a major advance in answering the needs of infants rely in making the mask more friendly user by making sucking on the infant's soother an integral part of the newly developed mask. This is based on the following premises:

  1. Sucking is a vital feeding and soothing activity of infants. Incorporating sucking into the act of aerosol delivery greatly reduces the fear engendered and inconvenience of putting an obtrusive mask on the infant's face.
  2. Linking the mask to the sucking action ensures a tight seal between the mask and the face. Every time the baby sucks on the pacifier or the bottle nipple, the mask is pressed onto the face by atmospheric pressure thus ensuring a good mask to face seal. This then also ensures that the aerosol that has been sprayed into the holding chamber will be drawn into the baby's lungs through the nose with each inspiration.
  3. The material of the mask's rim is relatively wide, soft, corrugated and is thus highly flexible. This makes the mask easily compressible without overdue force on the infant's face. Thus, the act of sucking attracts the mask to the child's face, assists in achieving a good seal and compresses it thus substantially reducing the dead space volume of the mask.

The ultimate goal of the present study is to answer these specific needs of infants and to develop an appropriate infant's oriented face mask. In order to achieve this goal the study will have three specific objectives.

Objective #1 Define morphometric data of infants' faces Objective #2 Design and develop an optimally adapted face mask SootherMask (SM) based on the morphometric results Objective #3 Compare the acceptance levels between Soothermask (SM) and a conventional commonly used masks without a pacifier.

Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Design and Development of an Infant's Oriented Face Mask
Study Start Date : April 2010
Estimated Primary Completion Date : April 2011
Estimated Study Completion Date : April 2012

Primary Outcome Measures :
  1. Acceptance levels of new infant face mask [ Time Frame: 10 minutes ]

    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.

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Ages Eligible for Study:   up to 4 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
hospitals,primary care clinic, community sample

Inclusion Criteria:

Signed informed consent

Exclusion Criteria:

Non cooperation with procedure

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01131663

Contact: Israel Amirav, MD 97246828712 amirav@012.net.il

Ziv Medical center Recruiting
Safed, Israel, 13100
Principal Investigator: Israel Amirav, MD         
Pediatric Department, Ziv Medical Center Recruiting
Safed, Israel
Contact: Israel Amirav, MD    9726828712    amirav@012.net.il   
Principal Investigator: Israel Amirav, MD         
Sponsors and Collaborators
Ziv Hospital
Principal Investigator: Israel Amirav, MD Ziv Medical Center

Responsible Party: Israel Amirav, Ziv Medical Center
ClinicalTrials.gov Identifier: NCT01131663     History of Changes
Other Study ID Numbers: 0063-09-ZIV
First Posted: May 27, 2010    Key Record Dates
Last Update Posted: May 27, 2010
Last Verified: May 2010

Keywords provided by Ziv Hospital:
Infants, aerosol, acceptance, face mask, drug delivery