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

NCT01120938 | Unknown

• 1 other identifier: 07-09
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Sudden Infant Death

Keywords

AIrways, Patency, Infant death

Outcome Measures

Primary Outcomes (1)

• Upper airway caliber and patency

  10-20 minutes

Eligibility Criteria

• Age: Up to 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

primary care clinic, community sample

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Ziv Hospital: lead

Study Sites (1)

Ziv Medical center

Safed, 13100, Israel

RECRUITING

Related Publications (1)

• 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.

  PMID: 24670428 DERIVED

MeSH Terms

Conditions

Sudden Infant Death; Infant Death

Condition Hierarchy (Ancestors)

Death, Sudden; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Israel Amirav, MD

  Ziv Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Israel Amirav, MD

CONTACT

97246828712; amirav@012.net.il

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: May 8, 2010
• First Posted: May 11, 2010
• Study Start: February 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2012
• Last Updated: May 26, 2010

Record last verified: 2010-05

Locations

IL (1)