Middle Ear Pressure Disregulation in Cleft Palate Patients

NCT00423072 | Completed

• 2 other identifiers: 06070091P50DC007667
• Study Type: observational
• Target: 82
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cleft Palate

Keywords

cleft palate; palatoplasty; otitis; middle ear; Eustachian tube

Outcome Measures

Primary Outcomes (1)

• otitis media

  status of middle ear at 5 years of age

  5 years

Secondary Outcomes (2)

• anatomic variables

  3 and 5 years

• Eustachian tube function testing

  pre- and post palatoplasty, yearly to age 18 yrs

Study Arms (1)

1

children with cleft palate birth-24 months of age

Eligibility Criteria

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

Study Population

Children with cleft palate \<2 years of age

You may qualify if:

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

You may not qualify if:

• cleft palate associated with syndrome
• known immune deficiency

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Institute on Deafness and Other Communication Disorders (NIDCD): collaborator

Study Sites (1)

ENT Research Center Childrens' Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (3)

• 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.

  PMID: 22230559 RESULT

• 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.

  PMID: 21740160 RESULT

• 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.

  PMID: 27533493 RESULT

MeSH Terms

Conditions

Cleft Palate; Otitis

Condition Hierarchy (Ancestors)

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

Study Officials

• Cuneyt M Alper, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Otolaryngology

Study Record Dates

• First Submitted: January 12, 2007
• First Posted: January 17, 2007
• Study Start: August 1, 2006
• Primary Completion: March 27, 2017
• Study Completion: May 22, 2017
• Last Updated: February 18, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)