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Mic-Key Versus Mini One Family Preference Comparison

NCT03041649 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 158

Last updated 2021-10-21

No results posted yet for this study

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

Interventions

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.

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.

Sponsors & Collaborators

  • Children's Mercy Hospital Kansas City

    lead OTHER

Principal Investigators

  • Shawn D St. Peter, MD · Children's Mercy Hospital Kansas City

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
1 Day
Max Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-30
Primary Completion
2020-04-30
Completion
2020-04-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03041649 on ClinicalTrials.gov