Mic-Key Versus Mini One Family Preference Comparison

NCT03041649 | Completed

• 1 other identifier: 16070489
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 1

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).

Conditions

Gastroesophageal Reflux; Feeding Disorder; Family Satisfaction

Keywords

Gastroesophageal Reflux; Feeding Disorder; Gastrostomy tube; Family Satisfaction; GT button; Enteral nutrition; Gastrostomy button

Outcome Measures

Primary Outcomes (1)

• Parent preference

  Parents will be asked which button they prefer to keep at the 4-month visit.

  4 months

Secondary Outcomes (1)

• Enteral Access Assessment Sheet

  Up to 4 years after button placement

Study Arms (2)

GT button change - Mic-Key

ACTIVE COMPARATOR

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

GT button change - Mini One

ACTIVE COMPARATOR

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

Interventions

GT button change - Mic-Key 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

GT button change - Mini One 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 - Mic-Key

Eligibility Criteria

• Age: 1 Day - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Mercy Hospital Kansas City: lead

Study Sites (1)

Children's Mercy Kansas City

Kansas City, Missouri, 64108, United States

Location

Related Publications (1)

• 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.

  PMID: 31834114 DERIVED

MeSH Terms

Conditions

Gastroesophageal Reflux; Feeding and Eating Disorders

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Shawn D St. Peter, MD

  Children's Mercy Hospital Kansas City

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2017
• First Posted: February 3, 2017
• Study Start: November 1, 2016
• Primary Completion: April 1, 2020
• Study Completion: April 1, 2020
• Last Updated: October 21, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)