Enteral Nutrition FeedingWeNeed2FEEDNCT07383272
We Need to FEED: Facilitating Enteral Education for Discharge
A study testing Education Intervention in people with Enteral Nutrition Feeding, run by University of Illinois Chicago at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Enteral Nutrition Feeding
- What is being tested?
- Education Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2026to 1 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Illinois at Chicago (UI Health)
Chicago, Illinois, 60612
Melba M Haberland, MSN, APRN, 312-996-7416, melbawi@uic.edu
Melba M Haberland, MSN, APRN
About this study
Official title: We Need to F.E.E.D.: Facilitating Enteral Education for Discharge - Improving the Quality of Discharge for Pediatric Patients With Enteral Tubes
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.
Read the detailed description
Objectives and Hypothesis Objective: The primary objective of the FEED project is to enhance the discharge process for pediatric patients with enteral nutrition, ensuring adequate education, all necessary supplies, orders, follow-up appointments are in place, thereby improving patient outcomes and reducing healthcare utilization. The secondary objective of the FEED project is to create a standardized enteral discharge protocol. Tertiary goal includes ensuring video swallow studies are completed inpatient to expedite feeding therapy
Hypothesis: The implementation of a structured discharge process for enteral nutrition patients will result in:
- Reduced number of calls to the NICU, PEDS, PICU, outpatient pediatric and GI departments.
- Decreased number of unplanned visits to emergency room, urgent care, clinic visits related to enteral nutrition issues.
- Improved parent confidence and competence in managing enteral nutrition at home.
- Streamlined access to early intervention and speech therapy services.
- Enhanced coordination and communication among healthcare providers. Needs Assessment: Gastrostomy tubes (G-tubes) are commonly utilized to facilitate nutrition, hydration, and medication administration in children who have chronic inadequate oral intake due to conditions such as dysphagia, neurological disorders, chronic illnesses, oncologic problems, and other clinical conditions leading to malnutrition. Although G-tube placement is generally safe and frequently performed among pediatric patients, complications such as tube blockage, infection, and over granulation tissue are reported at varying frequencies. Home care plays a significant role in the occurrence of these common, minor, and preventable complications.
Research indicates that families often face challenges in managing home care for children with G-tubes due to insufficient knowledge and inadequate discharge support from healthcare professionals. Many families report that they have not been adequately informed by healthcare providers during discharge, leading to difficulties in providing correct care and disease management. The primary issues in home care include feelings of guilt due to the necessity of tube feeding, difficulties in daily care arising from tube-related complications, and fear of potential complications associated with enteral nutrition. The long-term nature of enteral feeding with G-tubes further increases the burden of care on families.
The American Society for Parenteral and Enteral Nutrition (ASPEN) emphasizes the importance of providing discharge education to patients with chronic illnesses and specific nutritional needs and maintaining safe home nutrition. Implementing a standardized, evidence-based discharge education protocol is expected to improve treatment outcomes, increase caregiver knowledge, and reduce the burden of care and anxiety levels.
The FEED (Facilitating Enteral Education for Discharge) project addresses these identified needs by streamlining the discharge process for pediatric patients with enteral nutrition. The project aims to ensure that all necessary supplies, orders, and follow-up appointments are in place prior to discharge. It also focuses on providing comprehensive education and support to parents, thereby improving patient outcomes, reducing healthcare utilization, and enhancing coordination and communication among healthcare providers. By addressing these key areas, the FEED project aims to improve the overall care for pediatric patients with enteral nutrition, ultimately enhancing patient outcomes and reducing the healthcare burden on families.
- Conditions
- Enteral Nutrition Feeding
- Being tested
- Education Intervention
- Keywords
- education, feeding tube, g tube, ng tube, gj tube, parent education, pediatrics, patient education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Education Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: post hospital discharge-through study completion, an average 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2026
- Study start30 Sep 2026 (estimated)
- Primary completion31 Mar 2027 (estimated)
- Study completion1 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Enteral Nutrition FeedingStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kiranmai Gorla, MD, Study chair, UI Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07383272
- Sponsor's protocol ID
- STUDY2025-0139
- Other IDs
- NASPGHAN contract award 39608
- Acronym
- WeNeed2FEED
- Status last verified
- Sep 2026
- First submitted
- 21 Feb 2025
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual Participant Data (IPD) Sharing Statement 1\. Considerations for Data Sharing At this time, a final decision has not been made regarding the sharing of Individual Participant Data (IPD). Several factors influence whether IPD will be shared, including: Confidentiality and Privacy Concerns: Given the sensitive nature of patient and caregiver data, ensuring that all shared data is fully de-identified while maintaining participant privacy is a priority. Additional steps may be required to protect anonymity, which could impact data availability. Regulatory and Institutional Policies: Data-sharing decisions must align with institutional policies, HIPAA regulations, and ethical standards. Institutional Review Board (IRB) requirements may place restrictions on data distribution. Feasibility of Secure Data Sharing: Establishing a HIPAA-compliant, secure data-sharing platform requires resources. The availability of these resources will determine whether data can be shared responsibly
Publications
Goldberg E, Kaye R, Yaworski J, Liacouras C. Gastrostomy tubes: facts, fallacies, fistulas, and false tracts. Gastroenterol Nurs. 2005 Nov-Dec;28(6):485-93; quiz 493-4. doi: 10.1097/00001610-200511000-00004.
PubMed 16418584DeLegge, M (2019). Gastrostomy Tubes: Complications and their management, Up To Date DeLegge, M (2019). Gastrostomy Tubes: Placement and routine care, Up To Date
Crawley-Coha T. A practical guide for the management of pediatric gastrostomy tubes based on 14 years of experience. J Wound Ostomy Continence Nurs. 2004 Jul-Aug;31(4):193-200. doi: 10.1097/00152192-200407000-00007.
PubMed 15851861
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- We Need to F.E.E.D.: Facilitating Enteral Education for Discharge - Improving the Quality of Discharge for Pediatric Patients With Enteral Tubes
- ClinicalTrials.gov ID
- NCT07383272
- Acronym / sponsor ID
- WeNeed2FEED / STUDY2025-0139
- Conditions
- Enteral Nutrition Feeding
- Keywords
- education, feeding tube, g tube, ng tube, gj tube, parent education, pediatrics, patient education
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Study start
- 30 Sep 2026 (estimated)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 1 May 2028 (estimated)
- First posted
- 3 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Objectives and Hypothesis Objective: The primary objective of the FEED project is to enhance the discharge process for pediatric patients with enteral nutrition, ensuring adequate education, all necessary supplies, orders, follow-up appointments are in place, thereby improving patient outcomes and reducing healthcare utilization. The secondary objective of the FEED project is to create a standardized enteral discharge protocol. Tertiary goal includes ensuring video swallow studies are completed inpatient to expedite feeding therapy
Hypothesis: The implementation of a structured discharge process for enteral nutrition patients will result in:
- Reduced number of calls to the NICU, PEDS, PICU, outpatient pediatric and GI departments.
- Decreased number of unplanned visits to emergency room, urgent care, clinic visits related to enteral nutrition issues.
- Improved parent confidence and competence in managing enteral nutrition at home.
- Streamlined access to early intervention and speech therapy services.
- Enhanced coordination and communication among healthcare providers. Needs Assessment: Gastrostomy tubes (G-tubes) are commonly utilized to facilitate nutrition, hydration, and medication administration in children who have chronic inadequate oral intake due to conditions such as dysphagia, neurological disorders, chronic illnesses, oncologic problems, and other clinical conditions leading to malnutrition. Although G-tube placement is generally safe and frequently performed among pediatric patients, complications such as tube blockage, infection, and over granulation tissue are reported at varying frequencies. Home care plays a significant role in the occurrence of these common, minor, and preventable complications.
Research indicates that families often face challenges in managing home care for children with G-tubes due to insufficient knowledge and inadequate discharge support from healthcare professionals. Many families report that they have not been adequately informed by healthcare providers during discharge, leading to difficulties in providing correct care and disease management. The primary issues in home care include feelings of guilt due to the necessity of tube feeding, difficulties in daily care arising from tube-related complications, and fear of potential complications associated with enteral nutrition. The long-term nature of enteral feeding with G-tubes further increases the burden of care on families.
The American Society for Parenteral and Enteral Nutrition (ASPEN) emphasizes the importance of providing discharge education to patients with chronic illnesses and specific nutritional needs and maintaining safe home nutrition. Implementing a standardized, evidence-based discharge education protocol is expected to improve treatment outcomes, increase caregiver knowledge, and reduce the burden of care and anxiety levels.
The FEED (Facilitating Enteral Education for Discharge) project addresses these identified needs by streamlining the discharge process for pediatric patients with enteral nutrition. The project aims to ensure that all necessary supplies, orders, and follow-up appointments are in place prior to discharge. It also focuses on providing comprehensive education and support to parents, thereby improving patient outcomes, reducing healthcare utilization, and enhancing coordination and communication among healthcare providers. By addressing these key areas, the FEED project aims to improve the overall care for pediatric patients with enteral nutrition, ultimately enhancing patient outcomes and reducing the healthcare burden on families.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –Usual care group will receive usual care/education provided at UI health on feeding tubes. |
| Education | Experimental | Other: Education InterventionEducation Intervention provided to the intervention group. Intervention will include education handbook, onsite or via zoom education of g tube, question and answer. |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Education InterventionEducation 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. | Other | Education |
Primary outcome
Families Enteral tube knowledge:Change in Enteral Tube Knowledge Score From Baseline and post hospital discharge
Time frame: Baseline (while hospitalized prior to initial educational session in the hospital) and after discharge ( up to 3 months)
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).
Number of Unplanned Healthcare Visits Related to Enteral Tube Issues
Time frame: post hospital discharge-through study completion, an average 1 year
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Background: PubMed 16418584Goldberg E, Kaye R, Yaworski J, Liacouras C. Gastrostomy tubes: facts, fallacies, fistulas, and false tracts. Gastroenterol Nurs. 2005 Nov-Dec;28(6):485-93; quiz 493-4. doi: 10.1097/00001610-200511000-00004.
- BackgroundDeLegge, M (2019). Gastrostomy Tubes: Complications and their management, Up To Date DeLegge, M (2019). Gastrostomy Tubes: Placement and routine care, Up To Date
- Background: PubMed 15851861Crawley-Coha T. A practical guide for the management of pediatric gastrostomy tubes based on 14 years of experience. J Wound Ostomy Continence Nurs. 2004 Jul-Aug;31(4):193-200. doi: 10.1097/00152192-200407000-00007.
- Individual participant dataSharing planned: Undecided. Individual Participant Data (IPD) Sharing Statement 1. Considerations for Data Sharing At this time, a final decision has not been made regarding the sharing of Individual Participant Data (IPD). Several factors influence whether IPD will be shared, including: Confidentiality and Privacy Concerns: Given the sensitive nature of patient and caregiver data, ensuring that all shared data is fully de-identified while maintaining participant privacy is a priority. Additional steps may be required to protect anonymity, which could impact data availability. Regulatory and Institutional Policies: Data-sharing decisions must align with institutional policies, HIPAA regulations, and ethical standards. Institutional Review Board (IRB) requirements may place restrictions on data distribution. Feasibility of Secure Data Sharing: Establishing a HIPAA-compliant, secure data-sharing platform requires resources. The availability of these resources will determine whether data can be shared responsibly
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kiranmai Gorla, MD study chair
UI Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education Intervention in people with Enteral Nutrition Feeding, run by University of Illinois Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Melba M Haberland, MSN (312-996-7416 or 312-413-2801, melbawi@uic.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Families Enteral tube knowledge:Change in Enteral Tube Knowledge Score From Baseline and post hospital discharge (time frame: Baseline (while hospitalized prior to initial educational session in the hospital) and after discharge ( up to 3 months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07383272, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.