Furlow Palatoplasty With Tensor Tenopexy

NCT01535131 | Completed DMC

• 2 other identifiers: PRO11060248R01DC011524
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

Brief Summary

This study compares a standard method for palate repair (the Furlow palatoplasty) with a modification of that method to determine which, if either, is more effective in reducing the duration of middle-ear disease (fluid in the ear) in cleft palate patients.

Conditions

Otitis Media; Cleft Palate

Keywords

otitis media; cleft palate

Outcome Measures

Primary Outcomes (3)

• hearing status

  results of audiometric testing

  3-year visit

• otitis media status

  diagnosis of OM, presence/absence of ventilation tubes at time of 3-year visit

  3 years of age

• Eustachian tube function (ETF) measures

  ETF test results

  3-year visit

Secondary Outcomes (5)

• Pittsburgh Weighted Speech Score

  3 years of age

• nasalence ratio

  3 years of age

• McKay-Kummer SMAP test

  3 years of age

• duration of speech therapy

  by age 7 years

• need for revision palatoplasties

  by 7 years of age

Study Arms (2)

Furlow palatoplasty

ACTIVE COMPARATOR

standard procedure

Procedure: palatoplasty

modified Furlow palatoplasty

EXPERIMENTAL

standard procedure plus modification

Procedure: palatoplasty

Interventions

palatoplasty PROCEDURE

procedure to close cleft palate

Furlow palatoplasty; modified Furlow palatoplasty

Eligibility Criteria

• Age: Up to 15 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• cleft palate with or without cleft lip classified as Veau I through IV
• parental consent for procedure
• patients assigned to Drs. Losee, Davit, Grundwaldt, or Goldstein for palatoplasty
• children up to 15 months of age who have not had palatoplasty but have tympanostomy tubes

You may not qualify if:

• patients with syndromic clefts or genetic abnormalities

Sponsors & Collaborators

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

Study Sites (1)

Children's Hospital of Pittsburgh of UPMC

Pittsburgh, Pennsylvania, 15224, United States

Location

MeSH Terms

Conditions

Otitis Media; Cleft Palate

Condition Hierarchy (Ancestors)

Otitis; Ear Diseases; Otorhinolaryngologic Diseases; 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

Study Officials

• Cuneyt M Alper, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Otolaryngology

Study Record Dates

• First Submitted: February 7, 2012
• First Posted: February 17, 2012
• Study Start: February 28, 2012
• Primary Completion: December 23, 2019
• Study Completion: June 30, 2020
• Last Updated: August 1, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)