NCT01820689

Brief Summary

Purpose: Characterize the profile of tympanometric patients with cleft lip and palate in the post surgery period and correlate it with the time of palatoplasty. Methods: The sample consisted of 16 patients with cleft lip or palate totaling 32 ears treated at a Public University Hospital in Cuiabá (MT)- Brazil, in the post surgery moment that varied from three months to 33 years. Were sampled patients of both sexes, pediatrics and adults.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2012

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 18, 2013

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 29, 2013

Completed
Last Updated

March 29, 2013

Status Verified

March 1, 2013

Enrollment Period

8 months

First QC Date

March 18, 2013

Last Update Submit

March 26, 2013

Conditions

Bilateral Complete Cleft Lip and/or Alveolus

Outcome Measures

Primary Outcomes (1)

  • Tympanic membrane mobility

    Tympanic membrane mobility will be measured through the tympanometry and will be demonstrated through their complacency in ml.

    3 months to 33 years

Secondary Outcomes (1)

  • Time of palatoplasty

    3 months to 33 years

Study Arms (1)

Tympanometry measurement

EXPERIMENTAL
Other: Tympanometry measurement

Interventions

Tympanometry measurementOTHER

The tympanometry measurement will be verify and compared with the time of palatoplasty.

Tympanometry measurement

Eligibility Criteria

Age1 Year+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • cleft incisive trans unilateral or bilateral
  • post-foramen complete or incomplete

You may not qualify if:

  • isolated cleft lip
  • associated syndromes
  • malformation of ear

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • P A Rodrigues, Doctor

    HUJM

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

March 18, 2013

First Posted

March 29, 2013

Study Start

January 1, 2012

Primary Completion

September 1, 2012

Study Completion

November 1, 2012

Last Updated

March 29, 2013

Record last verified: 2013-03