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

Sudden Infant Death research study

What is the primary objective of 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.

Who is eligible to participate?

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 -

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Sudden Infant Death

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Study Status

Unknown status

Start Date: February 2010

Completed Date: December 2012

Phase:

Type: Observational

Design:

Primary Outcome: Upper airway caliber and patency

Secondary Outcome:

Study sponsors, principal investigator, and references

Principal Investigator: Israel Amirav, MD

Lead Sponsor: Ziv Hospital

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01120938

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