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Mic-Key Versus Mini One Family Preference Comparison (MicKeyVMini)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03041649
Recruitment Status : Active, not recruiting
First Posted : February 3, 2017
Last Update Posted : January 19, 2021
Sponsor:
Information provided by (Responsible Party):
Children's Mercy Hospital Kansas City

Brief Summary:

The objective of this study is to compare two low profile balloon gastrostomy button enteral feeding devices, both currently used as standard of medical care. The investigators aim to compare family preference and rate of complications between the two devices in a prospective cohort of children. This is the first step in comparing initial and long-term outcomes along with the need for seeking medical advice for gastrostomy site-related complications.

The secondary aim of this study is to follow this population long term (4 years) to document the prevalence of: granulation tissue, infection, skin breakdown, and how long the gastrostomy tube balloon remains functional (does not lose water).


Condition or disease Intervention/treatment Phase
Gastroesophageal Reflux Feeding Disorder Family Satisfaction Other: GT button change - Mic-Key Other: GT button change - Mini One Not Applicable

Detailed Description:

This is a single center prospective, randomized study with a crossover design, comparing two low profile balloon gastrostomy buttons (Figure 1), MIC-Key™ and MINI One™ that are routinely used at CMH. Each subject will be randomly assigned to one button type at the time of initial placement. After placement, standard practice is to perform the first gastrostomy change in the clinic at 2 months where the primary caregivers replace the button under supervision. Therefore, the initial device after randomization will remain in place for 2 months. At the first scheduled device change, the other type of button will replace the original gastrostomy button device. This will remain in place for another 2 months. At the routine visit at 4 months the parents will be asked to choose which button they prefer to keep. This will meet the primary outcome endpoint of the study. The investigators will continue to follow as many subjects as possible to 4 years in order to identify any potential differences in secondary end points.

A caregiver satisfaction survey is routinely used in the clinics. Parent responses to this survey will be also be used in the study analysis.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Mic-Key Versus Mini: A Prospective, Randomized Trial for Family Preference Comparing Low Profile Balloon Gastrostomy Buttons
Study Start Date : November 2016
Estimated Primary Completion Date : November 2024
Estimated Study Completion Date : November 2025

Arm Intervention/treatment
Active Comparator: GT button change - Mic-Key
Subjects randomized to the Mic-Key arm will have the Mic-Key button placed initially at surgery, and at the first gastrostomy change in the clinic at 2 months, will change to the Mini One button. At the routine 4-month visit, parents will be asked which button they prefer to keep.
Other: GT button change - Mini One
After 2 months with each button, parents will be asked which button they prefer at the 4-month post-operational follow-up visit.

Active Comparator: GT button change - Mini One
Subjects randomized to the Mini One arm will have the Mini One button placed initially at surgery, and at the first gastrostomy change in the clinic at 2 months, will change to the Mic-Key button. At the routine 4-month visit, parents will be asked which button they prefer to keep.
Other: GT button change - Mic-Key
After 2 months with each button, parents will be asked which button they prefer at the 4-month post-operational follow-up visit.




Primary Outcome Measures :
  1. Parent preference [ Time Frame: 4 months ]
    Parents will be asked which button they prefer to keep at the 4-month visit.


Secondary Outcome Measures :
  1. Enteral Access Assessment Sheet [ Time Frame: Up to 4 years after button placement ]
    Providers will complete a brief checklist of gastrostomy tube maintenance and site complications at the 2-month button change, 4-month visit, and all subsequent follow-up visits while the button while the G-tube remains in place.



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children ages 0-5 years of age requiring 0.8 cm or 1.0 cm gastrostomy feeding devices for enteral nutrition seen in the Surgery, GI or Special Care clinics
  • Gastrostomy placement after IRB approval (enrollment will continue until 170 evaluable subjects have completed the 4 month visit. Expected attrition for the 4 year follow-up is 40%.
  • English-speaking families

Exclusion Criteria:

  • Children with dermatologic conditions influencing gastrostomy site healing and tract epithelialization
  • Children with immunosuppression
  • Children with active malignancy requiring treatment
  • Inability to commit to 4 months follow up

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03041649


Locations
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United States, Missouri
Children's Mercy Kansas City
Kansas City, Missouri, United States, 64108
Sponsors and Collaborators
Children's Mercy Hospital Kansas City
Investigators
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Principal Investigator: Shawn D St. Peter, MD Children's Mercy Hospital Kansas City
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Children's Mercy Hospital Kansas City
ClinicalTrials.gov Identifier: NCT03041649    
Other Study ID Numbers: 16070489
First Posted: February 3, 2017    Key Record Dates
Last Update Posted: January 19, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Children's Mercy Hospital Kansas City:
Gastroesophageal Reflux
Feeding Disorder
Gastrostomy tube
Family Satisfaction
GT button
Enteral nutrition
Gastrostomy button
Additional relevant MeSH terms:
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Gastroesophageal Reflux
Feeding and Eating Disorders
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Mental Disorders