Eustachian Tube Growth and Development
20. februar 2019 opdateret af: Margaretha L. Casselbrant, University of Pittsburgh
Eustachian Tube Growth and Development: Anatomy/Function
This study is to measure over time (from 3 years until 13 years of age) Eustachian tube function (the way the Eustachian tube works) and facial growth in groups of children with two types of middle-ear disease and with little past middle-ear disease.
These measures will be used to determine if facial growth is related to improved Eustachian tube function, to see if the better function explains why young children who have middle-ear disease outgrow it as they get older, and to determine if these measures are different for the children in the three groups defined by disease history.
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
The existing literature documents an important role for the Eustachian tube (ET) in the pathogenesis and/or persistence of otitis media (OM).
Cross-sectional studies report a lower prevalence of OM in older children, a better ET pressure-regulating function in older children and age-related differences in ET form, length and width, and the vector orientation of the paratubal musculature.
These growth-related changes in ET structural relationships are demonstrably predictive of increasingly more efficient ET function (ETF) and, because the ET and paratubal musculature are intimately related to the cranial base, the vector orientation of the ET system can be reconstructed from osteological or radiographic data.
Together, these observations suggest that measurable, age-related changes in ET-paratubal muscle vector relationships are reflected in more efficient ETF and, by consequence, a decreased OM risk.
The overall goal of the proposed longitudinal study is to evaluate the validity of this hypothesis.
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
126
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Pennsylvania
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Pittsburgh, Pennsylvania, Forenede Stater, 15224
- ENT Research Center, Children's Hospital of Pittsburgh
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
3 år til 3 år (Barn)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Pediatric otolaryngology clinic
Beskrivelse
Inclusion Criteria:
- 3 years of age
- History of middle ear disease must fit into one of the 3 categories of ear history
- With or without patent tympanostomy tubes at time of entry
- Generally good health
Exclusion Criteria:
- Cleft palate or other syndromes predisposing to otitis
- History of significant orthodontic treatment or plan for such
- Cholesteatoma or other past ear surgery other than tubes
- Unable to cooperate for testing
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
|---|
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chronic otitis media with effusion (OME)
history of chronic effusion (3 months if both ears, 6 months if one ear, or 3 episodes of effusion each lasting for 2 months or longer)
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recurrent AOM
recurrent acute otitis media (3 episodes in 6 months or 4 episodes in 1 year)
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no OM
no history of significant otitis media (i.e., does not meet criteria for chronic OME or recurrent AOM)
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
change in Eustachian tube function
Tidsramme: 5 years
|
Eustachian tube function is tested yearly from age 3 years through age 7 years
|
5 years
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
change in craniofacial measures
Tidsramme: 5 years
|
cross-correlations of anthropometric variables obtained by facial measurements, with growth over 5 years
|
5 years
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
change in cephalometric variables
Tidsramme: 5 years
|
measurements obtained on cephalometric x-rays
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5 years
|
|
change in later Eustachian tube function
Tidsramme: 11 years
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Eustachian tube function tested yearly through 13 years of age
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11 years
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Studieleder: Margaretha Casselbrant, MD, PhD, University of Pittsburgh
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Casselbrant ML, Mandel EM, Seroky JT, Swarts JD, Doyle WJ. A pilot study of the ability of the forced response test to discriminate between 3-year-old children with chronic otitis media with effusion or with recurrent acute otitis media. Acta Otolaryngol. 2011 Nov;131(11):1150-4. doi: 10.3109/00016489.2011.603137. Epub 2011 Aug 17.
- Casselbrant ML, Swarts JD, Mandel EM, Doyle WJ. The Cephalic Index is not different among groups of children aged 36-48 months with chronic otitis media with effusion, recurrent acute otitis media and controls. Int J Pediatr Otorhinolaryngol. 2013 Mar;77(3):334-7. doi: 10.1016/j.ijporl.2012.11.002. Epub 2012 Dec 30.
- Casselbrant ML, Mandel EM, Seroky JT, Swarts JD, Doyle WJ. The forced-response test does not discriminate ears with different otitis media expressions. Laryngoscope. 2014 Nov;124(11):2619-23. doi: 10.1002/lary.24647. Epub 2014 Aug 11.
- Swarts JD, Casselbrant ML, Teixeira MS, Mandel EM, Richert BC, Banks JM, El-Wagaa J, Doyle WJ. Eustachian tube function in young children without a history of otitis media evaluated using a pressure chamber protocol. Acta Otolaryngol. 2014 Jun;134(6):579-87. doi: 10.3109/00016489.2014.882017.
- Mandel EM, Casselbrant ML, Richert BC, Teixeira MS, Swarts JD, Doyle WJ. Eustachian Tube Function in 6-Year-Old Children with and without a History of Middle Ear Disease. Otolaryngol Head Neck Surg. 2016 Mar;154(3):502-7. doi: 10.1177/0194599815620149. Epub 2015 Dec 1.
- Casselbrant ML, Mandel EM, Doyle WJ. Information on co-morbidities collected by history is useful for assigning Otitis Media risk to children. Int J Pediatr Otorhinolaryngol. 2016 Jun;85:136-40. doi: 10.1016/j.ijporl.2016.03.040. Epub 2016 Apr 11.
- Gremba AP, Weinberg SM, Swarts JD, Casselbrant ML. Craniofacial shape in children with and without a positive otitis media history. Int J Pediatr Otorhinolaryngol. 2016 May;84:110-5. doi: 10.1016/j.ijporl.2016.02.029. Epub 2016 Mar 5.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. august 2006
Primær færdiggørelse (Faktiske)
16. januar 2017
Studieafslutning (Faktiske)
24. august 2018
Datoer for studieregistrering
Først indsendt
12. januar 2007
Først indsendt, der opfyldte QC-kriterier
12. januar 2007
Først opslået (Skøn)
17. januar 2007
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
22. februar 2019
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
20. februar 2019
Sidst verificeret
1. februar 2019
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- #0605009
- 5P50DC007667-06 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
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