Middle Ear Pressure Disregulation in Cleft Palate Patients

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

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.

Study Overview

• Status: Completed
• Conditions: Cleft Palate

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 82

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • ENT Research Center Childrens' Hospital of Pittsburgh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 2 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Children with cleft palate <2 years of age

Description

Inclusion Criteria:

• birth-24 months
• unrepaired or recently repaired cleft palate

Exclusion Criteria:

• cleft palate associated with syndrome
• known immune deficiency

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
1; children with cleft palate birth-24 months of age

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
otitis media	status of middle ear at 5 years of age	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
anatomic variables	MRI data at 3 and 5 years in subset; cephalometric x-rays at 6 yr.	3 and 5 years
Eustachian tube function testing	either Forced Response testing or pressure chamber testing	pre- and post palatoplasty, yearly to age 18 yrs

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Collaborators: National Institute on Deafness and Other Communication Disorders (NIDCD)
• Investigators: Principal Investigator: Cuneyt M Alper, MD, University of Pittsburgh

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2006
• Primary Completion (Actual): March 27, 2017
• Study Completion (Actual): May 22, 2017

Study Registration Dates

• First Submitted: January 12, 2007
• First Submitted That Met QC Criteria: January 12, 2007
• First Posted (Estimate): January 17, 2007

Study Record Updates

• Last Update Posted (Actual): February 18, 2019
• Last Update Submitted That Met QC Criteria: February 14, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: cleft palate; Eustachian tube; otitis; middle ear; palatoplasty
• Additional Relevant MeSH Terms: Congenital Abnormalities; Musculoskeletal Diseases; Stomatognathic Diseases; Mouth Diseases; Mouth Abnormalities; Stomatognathic System Abnormalities; Jaw Abnormalities; Jaw Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Cleft Palate
• Other Study ID Numbers: 0607009; 1P50DC007667 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO