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Mic-Key Versus Mini One Family Preference Comparison

NCT ID: NCT03041649

Last Updated: 2021-10-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

158 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2020-04-30

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Gastroesophageal Reflux Feeding Disorder Family Satisfaction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

GT button change - Mini One

Intervention Type OTHER

After 2 months with each button, parents will be asked which button they prefer at the 4-month post-operational follow-up visit.

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.

Group Type ACTIVE_COMPARATOR

GT button change - Mic-Key

Intervention Type OTHER

After 2 months with each button, parents will be asked which button they prefer at the 4-month post-operational follow-up visit.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

1 Day

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Children's Mercy Hospital Kansas City

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shawn D St. Peter, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Mercy Hospital Kansas City

Locations

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Children's Mercy Kansas City

Kansas City, Missouri, United States

Site Status

Countries

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United States

References

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Abdelhadi RA, Dekonenko C, Dorman RM, Oyetunji TA, St Peter SD. A Prospective, Randomized Cross-over Trial of 2 Low-profile Gastrostomy Buttons to Determine Family Preference. J Pediatr Gastroenterol Nutr. 2020 Mar;70(3):386-388. doi: 10.1097/MPG.0000000000002585.

Reference Type DERIVED
PMID: 31834114 (View on PubMed)

Other Identifiers

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16070489

Identifier Type: -

Identifier Source: org_study_id