Feeding DifficultiesNCT07054983
Parent Tube Weaning Interviews
A study testing Qualitative Research Interview in people with Feeding Difficulties and Remote Patient Monitoring, run by Children's Mercy Hospital Kansas City at 1 site in United States.
Trial summary
Recent developments in remote monitoring software can provide a proactive means for data transfer for healthcare teams to communicate with families regarding activities like weaning from feeding tubes. Children's Mercy began utilizing a mHealth technology - CHAMP App® - for tube weaning in the Fall of 2023. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Feeding Difficulties, Remote Patient Monitoring, Pediatric Feeding Disorders
- What is being tested?
- Qualitative Research Interview
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jul 2025to Oct 2026
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults that are at least 18 years of age that are parent(s) of children with pediatric feeding disorder who have been seen in the Children's Mercy Interdisciplinary Feeding Clinic.
- Parent/Legal Guardian of a child < 6 years of age when they attempted tube weaning
- Pediatric patients that have attempted a tube wean in the last 3 years (2022-2025) with the Interdisciplinary Feeding Clinic through either standard of care or through utilization of the CHAMP App
Who cannot join
- Non-English-speaking parent(s)
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
Children's Mercy Hospital
Kansas City, Missouri, 64108
About this study
Official title: Parent-Caregiver Experience Tube Weaning in the Home Setting: A Qualitative Comparative Case Study
Recent developments in remote monitoring software can provide a proactive means for data transfer for healthcare teams to communicate with families regarding activities like weaning from feeding tubes. Children's Mercy began utilizing a mHealth technology - CHAMP App® - for tube weaning in the Fall of 2023. Research gaps remain in this population, including comparing the experiences of families who could wean with methods available prior to the innovative use of a medical team collaborating with mHealth technology. This will be a single site study with one-time naturalistic, semi-structured parent interviews of children who have attempted tube weaning in their homes with two different models of care (standard ambulatory tube weaning and with the CHAMP App pilot).
- Being tested
- Qualitative Research Interview
- Keywords
- Pediatric, Tube Weaning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Qualitative Research InterviewOther
Qualitative research interview of parents of pediatric patients seen in an interdisciplinary feeding clinic who underwent a tube weaning program
| Study group | Role | What they receive |
|---|---|---|
| Parents of children who attempted tube weaning | Other | Qualitative interviews of parents of pediatric patients who have previously attempted tube weaning via the CHAMP App Receives: Other: Qualitative Research Interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parental Perspective
Explore the parental perspectives of the process of weaning from feeding tubes to all calories by mouth while in the home setting to identify preference for weaning via remote health monitoring.
Measured: During the Tube weaning attempt, an average of 8 weeks
Secondary outcomes (4)
Communication
Determine differences in communication between parents and care teams during the weaning process.
Measured: During the Tube weaning attempt, an average of 8 weeks
Stress
Identify how parents perceive the tube feeding process with regards to stress.
Measured: During the Tube weaning attempt, an average of 8 weeks
Social Determinates of Health
Identify whether social determinates of health impact tube weaning for all families.
Measured: During the Tube weaning attempt, an average of 8 weeks
Access
Determine if having increased access to healthcare teams during the tube weaning process has an effect on the confidence of parents to complete the wean.
Measured: During the Tube weaning attempt, an average of 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2025
- Study start30 Jul 2025
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Feeding DifficultiesStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Interviews
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Mercy Hospital Kansas City
- Sponsor type
- University, hospital or other
- Collaborators
- The Gerber Foundation, Daisy Foundation
- Responsible party
- Principal investigator, Kristina Nash, Children's Mercy Hospital Kansas City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07054983
- Sponsor's protocol ID
- STUDY00003570
- Status last verified
- May 2026
- First submitted
- 4 Jun 2025
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parent-Caregiver Experience Tube Weaning in the Home Setting: A Qualitative Comparative Case Study
- ClinicalTrials.gov ID
- NCT07054983
- Acronym / sponsor ID
- STUDY00003570
- Keywords
- Pediatric, Tube Weaning
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Children's Mercy Hospital Kansas CityUniversity, hospital or other
- Collaborators
- The Gerber Foundation, Daisy Foundation
- Study start
- 30 Jul 2025 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 8 Jul 2025 (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.
Recent developments in remote monitoring software can provide a proactive means for data transfer for healthcare teams to communicate with families regarding activities like weaning from feeding tubes. Children's Mercy began utilizing a mHealth technology - CHAMP App® - for tube weaning in the Fall of 2023. Research gaps remain in this population, including comparing the experiences of families who could wean with methods available prior to the innovative use of a medical team collaborating with mHealth technology. This will be a single site study with one-time naturalistic, semi-structured parent interviews of children who have attempted tube weaning in their homes with two different models of care (standard ambulatory tube weaning and with the CHAMP App pilot).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Interviews
| Arm | Type | Receives |
|---|---|---|
| Parents of children who attempted tube weaning | Other | Other: Qualitative Research InterviewQualitative interviews of parents of pediatric patients who have previously attempted tube weaning via the CHAMP App |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults that are at least 18 years of age that are parent(s) of children with pediatric feeding disorder who have been seen in the Children's Mercy Interdisciplinary Feeding Clinic.
- Parent/Legal Guardian of a child < 6 years of age when they attempted tube weaning
- Pediatric patients that have attempted a tube wean in the last 3 years (2022-2025) with the Interdisciplinary Feeding Clinic through either standard of care or through utilization of the CHAMP App
Key exclusion criteria (1 listed)
- Non-English-speaking parent(s)
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 |
|---|---|---|
| Qualitative Research InterviewQualitative research interview of parents of pediatric patients seen in an interdisciplinary feeding clinic who underwent a tube weaning program | Other | Parents of children who attempted tube weaning |
Primary outcome
Parental Perspective
Time frame: During the Tube weaning attempt, an average of 8 weeks
Explore the parental perspectives of the process of weaning from feeding tubes to all calories by mouth while in the home setting to identify preference for weaning via remote health monitoring.
4 secondary outcomes
Communication
Time frame: During the Tube weaning attempt, an average of 8 weeks
Stress
Time frame: During the Tube weaning attempt, an average of 8 weeks
Social Determinates of Health
Time frame: During the Tube weaning attempt, an average of 8 weeks
Access
Time frame: During the Tube weaning attempt, an average of 8 weeks
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 15 May 2026.
- Individual participant dataSharing planned: No
Related trials for Feeding Difficulties
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Validation of the D-TAP Parental Questionnaire for Early Screening of Pediatric Feeding Disorder in Hospitalized Children Aged 8 to 18 Months
Pediatric Feeding Disorder, Feeding Difficulties in Infants and Young Children
Recruiting
The Effects of Pacifier-Activated Lullaby on Oral Feeding Among Preterm Infants
Dysphagia of Newborn
Enrolling by invitation
Effects of FEED@Home Intervention
Dementia, Dementia Severe
Enrolling by invitationObservational study
CHAMP For the Feeder: Tube Feeding Study
Feeding Disorders
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Qualitative Research Interview in people with Feeding Difficulties and Remote Patient Monitoring, run by Children's Mercy Hospital Kansas City 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 3 inclusion and 1 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: enrolling by invitation, as of the sponsor's last update on 15 May 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parental Perspective (time frame: During the Tube weaning attempt, an average of 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 May 2026.