Middle Ear Pressure Disregulation in Cleft Palate Patients

Cleft Palate Clinical Trial

Official title:

Middle Ear Pressure Disregulation in Cleft Palate Patients: Form-Function Correlates

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00423072
• Other study ID #: 0607009
• Secondary ID: 1P50DC007667
• Status: Completed
• Start date: August 2006
• Est. completion date: May 22, 2017

Study information

• Verified date: February 2019
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The investigators know that middle-ear disease is very common in infants with cleft palate and causes hearing loss that can last into childhood. It is thought that a poor ability to keep the pressure in the middle ear at a similar level to that in the environment causes middle-ear disease and that this depends on the opening function of a natural tube that connects the back of the nose with the middle ear, called the Eustachian tube. The investigators believe that the middle-ear disease in cleft palate infants and children is caused by poor Eustachian tube function that in turn is caused by anatomical problems in the muscles that open the tube. The investigators plan to test these relationships by studying the changes between 5-24 months and 6 years in middle-ear health, the way the Eustachian tube works and Eustachian tube anatomy in cleft palate children.

Description:

Otitis media with effusion (OME) is recognized as nearly universal in the population of infants and children with cleft palate (CP) and is often associated with long-standing conductive and, perhaps, sensorineural hearing losses. Most evidence suggests that OME in CP patients is a complication of inefficient Eustachian tube function (ETF). The investigators plan to use our most complete tests to characterize ETF in CP infants tested at age 5-24 months and followed up through age 6 years by yearly collection of clinical data for the presence/absence of OME and repeat ETF testing. To obtain anatomical data, the investigators will obtain basal and lateral cephalograms at age 3 years in all subjects and perform MRI tests prepalatoplasty when possible and then at 3 and 5 years on a subset of the enrolled children. Functional-anatomical reconstructions based on the MRI data will be studied for the mechanical interactions underlying the phenomenon of ET constriction in CP patients and examined for the possibility of surgical interventions to correct identified abnormal interactions.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: May 22, 2017
• Est. primary completion date: March 27, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 24 Months

Eligibility

Inclusion Criteria:

• birth-24 months

• unrepaired or recently repaired cleft palate

Exclusion Criteria:

• cleft palate associated with syndrome

• known immune deficiency

Related Conditions & MeSH terms

• Cleft Palate

Locations

Country	Name	City	State
United States	ENT Research Center Childrens' Hospital of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	National Institute on Deafness and Other Communication Disorders (NIDCD)

Country where clinical trial is conducted

United States, 

References & Publications (3)

Alper CM, Losee JE, Mandel EM, Seroky JT, Swarts JD, Doyle WJ. Postpalatoplasty Eustachian tube function in young children with cleft palate. Cleft Palate Craniofac J. 2012 Jul;49(4):504-7. doi: 10.1597/11-065. Epub 2011 Jul 8. — View Citation

Alper CM, Losee JE, Mandel EM, Seroky JT, Swarts JD, Doyle WJ. Pre- and post-palatoplasty Eustachian tube function in infants with cleft palate. Int J Pediatr Otorhinolaryngol. 2012 Mar;76(3):388-91. doi: 10.1016/j.ijporl.2011.12.017. Epub 2012 Jan 9. — View Citation

Alper CM, Losee JE, Seroky JT, Mandel EM, Richert BC, Doyle WJ. Resolution of Otitis Media With Effusion in Children With Cleft Palate Followed Through Five Years of Age. Cleft Palate Craniofac J. 2016 Sep;53(5):607-13. doi: 10.1597/15-130. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	otitis media	status of middle ear at 5 years of age	5 years
Secondary	anatomic variables	MRI data at 3 and 5 years in subset; cephalometric x-rays at 6 yr.	3 and 5 years
Secondary	Eustachian tube function testing	either Forced Response testing or pressure chamber testing	pre- and post palatoplasty, yearly to age 18 yrs