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Postoperative Controls of Ventilation Tubes in Children - by General Practitioner or Otolaryngologist? (ConVenTu)

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ClinicalTrials.gov Identifier: NCT02831985
Recruitment Status : Recruiting
First Posted : July 13, 2016
Last Update Posted : December 11, 2019
Sponsor:
Collaborators:
St. Olavs Hospital
Alesund Hospital
Kristiansund Hospital
Molde Hospital
Helse Stavanger HF
Sykehuset Innlandet HF
University Hospital of North Norway
Information provided by (Responsible Party):
Norwegian University of Science and Technology

Tracking Information
First Submitted Date  ICMJE February 19, 2016
First Posted Date  ICMJE July 13, 2016
Last Update Posted Date December 11, 2019
Actual Study Start Date  ICMJE August 15, 2017
Estimated Primary Completion Date April 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 11, 2016)
  • audiogram [ Time Frame: 2 years ]
    pure tone thresholds in decibel (dB) at 0.25-0.5-1-2-4 kHz
  • audiogram [ Time Frame: 4 years ]
    pure tone thresholds in decibel (dB) at 0.25-0.5-1-2-4 kHz
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Postoperative Controls of Ventilation Tubes in Children - by General Practitioner or Otolaryngologist?
Official Title  ICMJE Postoperative Controls of Ventilation Tubes in Children - by General Practitioner or Otolaryngologist? A Multicenter Randomized Controlled Trial (The ConVenTu Study)
Brief Summary

A large number of children with otitis media undergo surgery with ventilation tubes (VTs) placed in the tympanic membrane. This is done to improve hearing and speech development and to reduce ear complaints. The long-term results of VTs are unclear. Follow-up care is required to assure that the tubes are functional, hearing loss has been corrected, and potential complications are properly diagnosed and managed. Guidelines regarding follow-up care give different advices concerning when, how and by whom the controls should be made.

The primary goal of this study is to investigate if follow-up care after surgery with VTs of children aged 3-10 years can be done by general practitioners instead of specialists without negative consequences for the patient.

In the study the child`s hearing and speech development, middle ear function, subjective complaints and complications will be assessed. User satisfaction and other aspects related to the quality of control will also be assessed.

If the study shows that follow-ups after surgery with VTs can be done on the level of primary care without loss of care quality, specialist health care services will be spared and cost-effectiveness for the overall healthcare system will improve.

Detailed Description Remark: the change in age range of included children from 4-10 to 3-10 was approved by REK (ethics committee) in November 2018.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE Otitis
Intervention  ICMJE
  • Procedure: general practice follow-up
    Post-surgery follow-up by general practitioner
  • Procedure: ear-nose-throat (ENT) specialist follow-up
    Post-surgery follow-up by ear-nose-throat (ENT) specialist
Study Arms  ICMJE
  • Experimental: general practice follow-up
    post-surgery follow-up by general practitioner
    Intervention: Procedure: general practice follow-up
  • Active Comparator: ENT specialist follow-up
    post-surgery follow-up by ear-nose-throat (ENT) specialist
    Intervention: Procedure: ear-nose-throat (ENT) specialist follow-up
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 8, 2017)
400
Original Estimated Enrollment  ICMJE
 (submitted: July 11, 2016)
314
Estimated Study Completion Date  ICMJE April 2021
Estimated Primary Completion Date April 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Insertion of a ventilation tube in at least one ear
  • patient at Trondheim University Hospital, Molde Hospital, Aalesund Hospital, Kristiansund Hospital, Stavanger Hospital, Hospital North Norway, or Innlandet Hospital in Gjøvik.

Exclusion Criteria:

  • Medical syndromes or other co-existing severe disease that possibly result in increased complication rate after insertion of ventilation tubes, i.e. Downs Syndrome, Cystic Fibrosis, Primary Ciliary Dyskinesia
  • Auditory processing disorder (APD)
  • Severe neurogenic hearing loss (HL) at least one ear (> 50dB HL in frequencies 0.25 - 4.0 KHz)
  • Guardians or children who do not master the Norwegian language
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Years to 10 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Ann Helen Nilsen 0047 72575376 ann.helen.nilsen@stolav.no
Contact: Bjarne Austad, PhD bjarne.austad@ntnu.no
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02831985
Other Study ID Numbers  ICMJE ISM-INM/2015/03-1
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Norwegian University of Science and Technology
Study Sponsor  ICMJE Norwegian University of Science and Technology
Collaborators  ICMJE
  • St. Olavs Hospital
  • Alesund Hospital
  • Kristiansund Hospital
  • Molde Hospital
  • Helse Stavanger HF
  • Sykehuset Innlandet HF
  • University Hospital of North Norway
Investigators  ICMJE
Principal Investigator: Wencke Moe Thorstensen, PhD Norwegian University of Science and Technology
Study Director: Anne S Helvik, PhD Norwegian University of Science and Technology
PRS Account Norwegian University of Science and Technology
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP