NCT07383272

Brief Summary

Aim: We need to FEED (Facilitating Enteral Education for Discharge) project aims to streamline and enhance the discharge process for pediatric patients with enteral nutrition (including G-tubes, J-tubes, GJ-tubes, and NG-tubes) and ultimately create enteral discharge protocol. The aim of the study is to describe the effectiveness of the discharge education program for children with enteral tubes on caregiver knowledge and determine the impact of the program on unplanned ER, Urgent care or clinic visits. By ensuring that all necessary supplies, orders, and follow-up appointments are in place prior to discharge, and by providing comprehensive education and support to parents, the project seeks to improve patient outcomes, reduce healthcare utilization, enhance coordination and communication among healthcare providers.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
24mo left

Started Apr 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress5%
Apr 2026May 2028

First Submitted

Initial submission to the registry

February 21, 2025

Completed
12 months until next milestone

First Posted

Study publicly available on registry

February 3, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2027

Expected
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2028

Last Updated

March 25, 2026

Status Verified

January 1, 2026

Enrollment Period

12 months

First QC Date

February 21, 2025

Last Update Submit

March 24, 2026

Conditions

Enteral Nutrition Feeding

Keywords

educationfeeding tubeg tubeng tubegj tubeparent educationpediatricspatient education

Outcome Measures

Primary Outcomes (2)

  • Families Enteral tube knowledge:Change in Enteral Tube Knowledge Score From Baseline and post hospital discharge

    Enteral tube knowledge will be measured using a enteral nutrition knowledge likert scale survey at baseline (hospitalized: at time of feeding tube placement and post discharge. Knowledge scores will be compared between the intervention group (FEED Program) and the control group (usual care).

    Baseline (while hospitalized prior to initial educational session in the hospital) and after discharge ( up to 3 months)

  • Number of Unplanned Healthcare Visits Related to Enteral Tube Issues

    The number of unplanned healthcare visits (emergency department visits, urgent care visits, and unplanned outpatient visits) related to enteral tube complications will be tracked. Data will be compared between the intervention group (FEED Program) and the control group (usual care) to evaluate the program's impact on reducing unplanned healthcare utilization.

    post hospital discharge-through study completion, an average 1 year

Study Arms (2)

Usual Care

NO INTERVENTION

Usual care group will receive usual care/education provided at UI health on feeding tubes.

Education

EXPERIMENTAL

Education Intervention provided to the intervention group. Intervention will include education handbook, onsite or via zoom education of g tube, question and answer.

Other: Education Intervention

Interventions

Education InterventionOTHER

Education on feeding tubes, booklet, inperson or via zoom education to parents of pediatric patients with newly placed feeding tube ( G-tube, GJ-tube, NG tube). Education on supply company and how to get supplies. The need for back up feeding tube etc. Size of patient feeding tube.

Education

Eligibility Criteria

AgeUp to 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Patients must be within the age range of 0 to 17 years.
  • Patients who have recently had an enteral feeding tube placed (G-tube, J-tube, GJ-tube, or NG-tube).
  • The patient must be hospitalized at the time of the study and scheduled for discharge within the study period (before discharge).
  • A legal guardian must be available to participate in the study, complete questionnaires, and engage in the educational sessions.
  • Both the pediatric patient and their caregiver must be willing to participate in the study, including completing surveys and receiving educational materials.

You may not qualify if:

  • Patients who have had an enteral tube (G-tube, J-tube, GJ-tube, or NG-tube) for more than a short period (e.g., those who have had tubes in place for more than 3 months) may be excluded, as the study is focused on newly placed feeding tubes.
  • Patients aged 18 years or older are excluded from the study, as the project targets pediatric patients specifically.
  • If the caregiver (or the child, where applicable) has significant cognitive or language barriers that would prevent them from understanding the educational content or completing the surveys, they may be excluded.
  • Families who do not speak English may be excluded.
  • Patients with significant comorbidities or unstable clinical conditions that would make participation in the discharge education protocol impractical will be excluded. This includes, but is not limited to, patients with severe respiratory failure requiring nitric oxide therapy, hemodynamic instability requiring blood pressure medications (e.g., vasopressors), or other acute medical conditions requiring active intensive care. Patients who are stable and preparing for discharge, even after a prolonged NICU or PICU stay, will not be excluded.
  • Only legal guardian can enroll child.
  • Patients whose caregivers are unable or unwilling to adhere to study protocols (e.g., participating in follow-up assessments or completing questionnaires) may be excluded to ensure consistency and reliable data collection.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Illinois at Chicago (UI Health)

Chicago, Illinois, 60612, United States

Location

Related Publications (3)

  • Goldberg E., Kaye R., Yaworski J., Liacouras C. (2005). Gastrostomy tubes: facts, fallacies, fistulas and false tracts. Gastroenterology Nursing, 28(6): 485-493.

    BACKGROUND

  • DeLegge, M (2019). Gastrostomy Tubes: Complications and their management, Up To Date DeLegge, M (2019). Gastrostomy Tubes: Placement and routine care, Up To Date

    BACKGROUND

  • Crawley-Coha, T. (2004). A practical guide for the management of pediatric gastrostomy tubes based on 14 years' experience. Journal of Wound Ostomy and Continence Nursing, July/Aug 193-200.

    BACKGROUND

MeSH Terms

Interventions

Early Intervention, Educational

Intervention Hierarchy (Ancestors)

Child Health ServicesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPreventive Health Services

Study Officials

  • Kiranmai Gorla, MD

    UI Health

    STUDY CHAIR

Central Study Contacts

Melba M Haberland, MSN

CONTACT

312-996-7416 or 312-413-2801melbawi@uic.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SEQUENTIAL
Model Details: Investigators will have pre and post test for both the control and intervention group. the pretest will be administered before the education intervention is applied. This will be a quasi-experiemental design.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 21, 2025

First Posted

February 3, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

May 1, 2028

Last Updated

March 25, 2026

Record last verified: 2026-01

Locations

US(1)