Sudden Infant DeathNCT01120938
Do Pacifiers Protect From Sudden Infant Death Syndrome (SIDS) Through an Increase in Upper Airway Patency?
An observational study of Sudden Infant Death, run by Ziv Hospital at 1 site in Israel.
Trial summary
Sudden infant death syndrome (SIDS) is the leading cause of death among infants between 1 month and 1 year of age in the developed world. SIDS continues to be a phenomenon of unknown cause. The best approach to for prevention in high risk infants is unclear. Read more about this study
- Who is it for?
- Ages Up to 24 months
- Conditions the study is for
- Sudden Infant Death
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- Feb 2010to Dec 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 24 months
- All sexes
- No healthy volunteers
- Child
Study population: primary care clinic, community sample
Who may be able to join
- -Infants who have been referred for clinical examination of MR (or CT with and without contrast) of the brain and neck -
- Regular (at least 2 hours a day) of a pacifier
Who cannot join
- -Infants who have histories and/or signs, or symptoms of airway abnormalities -
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Ziv Medical center
Safed, 13100
Israel Amirav, MD
About this study
Sudden infant death syndrome (SIDS) is the leading cause of death among infants between 1 month and 1 year of age in the developed world. SIDS continues to be a phenomenon of unknown cause. The best approach to for prevention in high risk infants is unclear. Several substantial lines of evidence indicate that pacifiers have a protective effect on the incidence of SIDS. These studies were significantly powered and the results were consistent world-wide. The explanation for the protective effects of pacifiers on SIDS prevalence is unclear. A recent case report from New Zealand showed by means of nasopharyngeal films of a baby with and without a pacifier the possibility that sucking on a pacifier is associated with a forward movement of the tongue with enlargement of the upper airways' cross sectional area. Indeed, this hypothesis was originally postulated 30 years ago by Cozzi et al.
Working hypothesis and aims: Our hypothesis is that since the upper respiratory tract is that portion of the airway that imposes the greatest resistance to ventilation, sucking on a pacifier results in upper airway dilatation, thus greatly reducing upper airway obstruction and improving ventilation at a stage when infants are virtually obligate nasal breathers. It should be stressed that airway resistance is proportional to the 3rd power of the radius of the airway, thus even a relatively small increase in airway diameter may have a profound effect on airway resistance and respiratory mechanical work of breathing! In young infants and those with underdeveloped respiratory center drive, this decrease in the work of breathing could certainly be sufficient to minimize the risk of SIDS as described above.Thus, the aim of this study is to demonstrate the effect of sucking on a pacifier on upper airway patency.
Read the detailed description
Ten to 12 infants' parents who have been referred for clinical examination of MR (or CT with and without contrast) of the brain and neck and who require sedation to perform this examination will be asked to participate in the study. These infants represent a potentially ideal population in which to study the upper airway. They are already undergoing MR/CT, their upper airways images are recorded, are asleep, and do not typically have airway abnormalities. In these children, 2 images of the upper airways -one obtained while with and one obtained while without a pacifier -will be analyzed and compared. In no case will additional sedation be given to obtain the MR/CT images of the airway. If the patient begins to wake up during the investigational sequence, the sequence will be aborted.
To test our hypothesis using the functional method, we will compare LRT aerosol penetration with and without a pacifier.
Infants who are regular pacifier users and are receiving therapeutic aerosols regularly (e.g., ventolin, budicort) will be studied. Labeling the aerosol particles with a gamma emitting isotope marker and quantifying its deposition scintigraphically by means of a gamma camera is a simple, safe and commonly used method to assess aerosol deposition throughout the URT and LRT.
- Conditions
- Sudden Infant Death
- Keywords
- AIrways, Patency, Infant death
- Medical subject headings
- Sudden Infant Death, Infant Death
What is being measured
The primary outcome is the main question the study is designed to answer.
Upper airway caliber and patency
Measured: 10-20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2010 (estimated)
- Study startFeb 2010
- Primary completionDec 2010 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sudden Infant DeathStudies 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 crossover
- Time perspective
- Prospective
- Enrolment
- 30 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
- NCT01120938
- Sponsor's protocol ID
- 07-09
- Status last verified
- May 2010
- First submitted
- 8 May 2010
- Last updated
- 26 May 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Amirav I, Newhouse MT, Luder A, Halamish A, Omar H, Gorenberg M. Feasibility of aerosol drug delivery to sleeping infants: a prospective observational study. BMJ Open. 2014 Mar 26;4(3):e004124. doi: 10.1136/bmjopen-2013-004124.
PubMed 24670428
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do Pacifiers Protect From Sudden Infant Death Syndrome (SIDS) Through an Increase in Upper Airway Patency?
- ClinicalTrials.gov ID
- NCT01120938
- Acronym / sponsor ID
- 07-09
- Conditions
- Sudden Infant Death
- Keywords
- AIrways, Patency, Infant death
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Ziv HospitalOther government
- Study start
- Feb 2010
- Primary completion
- Dec 2010 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 11 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.
Sudden infant death syndrome (SIDS) is the leading cause of death among infants between 1 month and 1 year of age in the developed world. SIDS continues to be a phenomenon of unknown cause. The best approach to for prevention in high risk infants is unclear. Several substantial lines of evidence indicate that pacifiers have a protective effect on the incidence of SIDS. These studies were significantly powered and the results were consistent world-wide. The explanation for the protective effects of pacifiers on SIDS prevalence is unclear. A recent case report from New Zealand showed by means of nasopharyngeal films of a baby with and without a pacifier the possibility that sucking on a pacifier is associated with a forward movement of the tongue with enlargement of the upper airways' cross sectional area. Indeed, this hypothesis was originally postulated 30 years ago by Cozzi et al.
Working hypothesis and aims: Our hypothesis is that since the upper respiratory tract is that portion of the airway that imposes the greatest resistance to ventilation, sucking on a pacifier results in upper airway dilatation, thus greatly reducing upper airway obstruction and improving ventilation at a stage when infants are virtually obligate nasal breathers. It should be stressed that airway resistance is proportional to the 3rd power of the radius of the airway, thus even a relatively small increase in airway diameter may have a profound effect on airway resistance and respiratory mechanical work of breathing! In young infants and those with underdeveloped respiratory center drive, this decrease in the work of breathing could certainly be sufficient to minimize the risk of SIDS as described above.Thus, the aim of this study is to demonstrate the effect of sucking on a pacifier on upper airway patency.
Detailed description
Ten to 12 infants' parents who have been referred for clinical examination of MR (or CT with and without contrast) of the brain and neck and who require sedation to perform this examination will be asked to participate in the study. These infants represent a potentially ideal population in which to study the upper airway. They are already undergoing MR/CT, their upper airways images are recorded, are asleep, and do not typically have airway abnormalities. In these children, 2 images of the upper airways -one obtained while with and one obtained while without a pacifier -will be analyzed and compared. In no case will additional sedation be given to obtain the MR/CT images of the airway. If the patient begins to wake up during the investigational sequence, the sequence will be aborted.
To test our hypothesis using the functional method, we will compare LRT aerosol penetration with and without a pacifier.
Infants who are regular pacifier users and are receiving therapeutic aerosols regularly (e.g., ventolin, budicort) will be studied. Labeling the aerosol particles with a gamma emitting isotope marker and quantifying its deposition scintigraphically by means of a gamma camera is a simple, safe and commonly used method to assess aerosol deposition throughout the URT and LRT.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- primary care clinic, community sample
Key inclusion criteria (2 listed)
- -Infants who have been referred for clinical examination of MR (or CT with and without contrast) of the brain and neck -
- Regular (at least 2 hours a day) of a pacifier
Key exclusion criteria (1 listed)
- -Infants who have histories and/or signs, or symptoms of airway abnormalities -
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
Upper airway caliber and patency
Time frame: 10-20 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2010.
- Derived from this study: PubMed 24670428Amirav I, Newhouse MT, Luder A, Halamish A, Omar H, Gorenberg M. Feasibility of aerosol drug delivery to sleeping infants: a prospective observational study. BMJ Open. 2014 Mar 26;4(3):e004124. doi: 10.1136/bmjopen-2013-004124.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sudden Infant Death, run by Ziv Hospital at 1 site 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 2 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 26 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 1 site 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?
Upper airway caliber and patency (time frame: 10-20 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01120938, which also lists 1 linked publication.
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 26 May 2010.