InfantNCT01131663
Design and Development of an Infant's Oriented Face Mask
An observational study of Infant, run by Ziv Hospital at 2 sites in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 4 yearsHealthy volunteers can take part
- Conditions the study is for
- Infant
- How many people
- 200 participants
- Where
- 2 sitesIsrael
- Study dates
- Apr 2010to Apr 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 4 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: hospitals,primary care clinic, community sample
Who may be able to join
- Signed informed consent
Who cannot join
- Non cooperation with procedure
Trial locations and contacts
2 sites in 1 country.
Israel2 sites, 2 recruiting
- Recruiting
Ziv Medical center
Safed, 13100
Israel Amirav, MD
- Recruiting
Pediatric Department, Ziv Medical Center
Safed
Israel Amirav, MD, 9726828712, amirav@012.net.il
Israel Amirav, MD
About this study
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.
Read the 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:
- 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.
- 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.
- 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.
- Conditions
- Infant
- Keywords
- Infants, aerosol, acceptance, face mask, drug delivery
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2010 (estimated)
- Study startApr 2010
- Primary completionApr 2011 (estimated)
- Study completionApr 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ziv Hospital
- Sponsor type
- Other government
- Investigators
- Israel Amirav, MD, Principal investigator, Ziv Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01131663
- Sponsor's protocol ID
- 0063-09-ZIV
- Status last verified
- May 2010
- First submitted
- 25 May 2010
- Last updated
- 27 May 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Design and Development of an Infant's Oriented Face Mask
- ClinicalTrials.gov ID
- NCT01131663
- Acronym / sponsor ID
- 0063-09-ZIV
- Conditions
- Infant
- Keywords
- Infants, aerosol, acceptance, face mask, drug delivery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Ziv HospitalOther government
- Study start
- Apr 2010
- Primary completion
- Apr 2011 (estimated)
- Study completion
- Apr 2012 (estimated)
- First posted
- 27 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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.
- 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.
- 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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 4 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- hospitals,primary care clinic, community sample
Key inclusion criteria (1 listed)
- Signed informed consent
Key exclusion criteria (1 listed)
- Non cooperation with procedure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2010.
Related trials for Infant
Recruiting
Effect of Support for Low-Income Mothers of Preterm Infants
Preterm Birth, Low; Birthweight, Extremely (999 Grams or Less)
Recruiting
Maximising Maternal Milk for Preterm Infant
Breastfeeding, Prematurity
Not yet recruitingObservational study
Clinical Genetics Branch Eligibility Screening Survey
Melanoma, Li-Fraumeni Syndrome
RecruitingObservational study
Hospital-Based Prospective Cohort of Malnutrition Under 6-Month Study (HOSPIC-6-Study)
Malnutrition, Infant, Malnutrition
RecruitingObservational study
Natural History of Bronchiectasis
Bronchiectasis, Cystic Fibrosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Israel Amirav, MD principal investigator
Ziv Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infant, run by Ziv Hospital at 2 sites in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 May 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Israel Amirav, MD (97246828712, amirav@012.net.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptance levels of new infant face mask (time frame: 10 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2010.