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NCT Number: NCT00423072

Middle Ear Pressure Disregulation in Cleft Palate Patients

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.

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Key information

Conditions

Cleft Palate Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Craniofacial Abnormalities Ear Diseases Jaw Abnormalities Jaw Diseases Maxillofacial Abnormalities Mouth Abnormalities Mouth Diseases Musculoskeletal Abnormalities Musculoskeletal Diseases Otitis Otorhinolaryngologic Diseases Stomatognathic Diseases Stomatognathic System Abnormalities

Age range

Up to 24 month

Sex eligibility

All sexes

Study type

Observational

Primary location

ENT Research Center Childrens' Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • cleft palate associated with syndrome
  • known immune deficiency

Treatment and study plan

Primary outcomes

  1. otitis media

    Time frame: 5 years

    status of middle ear at 5 years of age

Secondary outcomes

  1. anatomic variables

    Time frame: 3 and 5 years

    MRI data at 3 and 5 years in subset; cephalometric x-rays at 6 yr.

  2. Eustachian tube function testing

    Time frame: pre- and post palatoplasty, yearly to age 18 yrs

    either Forced Response testing or pressure chamber testing

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • National Institute on Deafness and Other Communication Disorders (NIDCD)

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2017
Study completion
2017
First posted
Jan 17, 2007
Registry last updated
Feb 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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