An observational study in Infant, sponsored by Ziv Hospital. Status unknown at 2 sites in Israel. Open to participants aged Up to 4 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-05-27.
Sponsored by Ziv Hospital · Observational
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.
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:
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.
Ziv Hospital is the lead sponsor of 82 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
hospitals,primary care clinic, community sample
Signed informed consent
Exclusion Criteria:
Non cooperation with procedure
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.
Time frame: 10 minutes
This study is status unknown, as verified in May 2010. You cannot join it, but the record below documents what was studied.
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Ziv Hospital