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Do Pacifiers Protect From Sudden Infant Death Syndrome (SIDS) Through an Increase in Upper Airway Patency?

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01120938
Recruitment Status : Unknown
Verified May 2010 by Ziv Hospital.
Recruitment status was:  Recruiting
First Posted : May 11, 2010
Last Update Posted : May 26, 2010
Information provided by:
Ziv Hospital

Brief 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. 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.

Condition or disease
Sudden Infant Death

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.

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: Do Pacifiers Protect From Sudden Infant Death Syndrome (SIDS) Through an Increase in Upper Airway Patency?
Study Start Date : February 2010
Estimated Primary Completion Date : December 2010
Estimated Study Completion Date : December 2012

Primary Outcome Measures :
  1. Upper airway caliber and patency [ Time Frame: 10-20 minutes ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   up to 24 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
primary care clinic, community sample

Inclusion Criteria:

-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

Exclusion Criteria:

-Infants who have histories and/or signs, or symptoms of airway abnormalities -

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 identifier (NCT number): NCT01120938

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Contact: Israel Amirav, MD 97246828712

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Ziv Medical center Recruiting
Safed, Israel, 13100
Principal Investigator: Israel Amirav, MD         
Sponsors and Collaborators
Ziv Hospital
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Principal Investigator: Israel Amirav, MD Ziv Medical Center
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Israel Amirav MD, Ziv Medical center Identifier: NCT01120938    
Other Study ID Numbers: 07-09
First Posted: May 11, 2010    Key Record Dates
Last Update Posted: May 26, 2010
Last Verified: May 2010
Keywords provided by Ziv Hospital:
AIrways, Patency, Infant death
Additional relevant MeSH terms:
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Infant Death
Sudden Infant Death
Pathologic Processes
Death, Sudden