Feeding Disorder NeonatalFASTNCT06118697
Feasibility of Aerodigestive Stimulation Therapy Trial
A study testing Esophageal stimulation with high resolution esophageal manometry and nutritive oral feeding therapy in people with Feeding Disorder Neonatal, run by Sudarshan Jadcherla at 1 site in United States.
Trial summary
The goal of this study is to demonstrate safety, feasibility, and efficacy of a novel pharyngo-esophageal stimulation technique in restoring aerodigestive and swallowing functions in select infants at-risk for chronic gavage tube feeding or gastrostomy. Read more about this study
- Who is it for?
- Ages 1 day to 8 months
- Conditions the study is for
- Feeding Disorder Neonatal
- What is being tested?
- Esophageal stimulation with high resolution esophageal manometry and nutritive oral feeding therapy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Feb 2024to 1 Nov 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 1 day to 8 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- NICU infant ≥37 weeks postmenstrual age not taking full oral feeds
- Consult to Neonatal \& Infant Feeding Disorder Program for oral feeding difficulty with diagnostic manometry ordered
- Presence of peristaltic and sphincteric reflexes at initial manometry
Who cannot join
- Potentially lethal chromosomal anomalies
- Craniofacial malformations
- Foregut malformations
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, 1 recruiting
- Recruiting
Nationwide Children's Hospital
Columbus, Ohio, 43205
About this study
Official title: Safety and Feasibility of Aerodigestive Stimulation Therapy in Infants With Complex Feeding Difficulties
The goal of this study is to demonstrate safety, feasibility, and efficacy of a novel pharyngo-esophageal stimulation technique in restoring aerodigestive and swallowing functions in select infants at-risk for chronic gavage tube feeding or gastrostomy. The main aims are:
- To provide consistent activation of deglutition (the process of swallowing), swallowing-airway interactions, and peristalsis in order to decrease the risk of home tube feeding.
- To examine whether physical and manometric evidence-guided interventions and biofeedback will improve compliance, minimize parental stress, and increase satisfaction and perceived self-confidence with infant feeding.
Participants will have weekly pharyngo-esophageal stimulation guided by High Resolution Impedance Manometry (HRIM) for 4 weeks or until discharge, oral nutritive stimulation of at least 5 mL of prescribed milk with each feed, and weekly parental education and feedback regarding feeding progress.
Read the detailed description
Stimulation will be provided to the esophagus using esophageal manometry starting at enrollment and then weekly for 4 weeks or until discharge, whichever occurs first. During the 4 weeks of study enrollment, subjects will also be provided nutritive oral feeding therapy with each care with a minimum of 5 mL of their prescribed feed. Feeding evaluations by a study team member will occur once a day during the length of the 4-week trial. The study team will do weekly rounds at the bedside to evaluate feeding progress and study interventions. A feeding plan will be posted at the bedside for clear communication with the care team and family of the subjects.
- Conditions
- Feeding Disorder Neonatal
- Being tested
- Esophageal stimulation with high resolution esophageal manometry and nutritive oral feeding therapy
- Keywords
- Chronic tube feeding, Gastrostomy, Deglutition, Esophageal manometry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Esophageal stimulation with high resolution esophageal manometry and nutritive oral feeding therapyProcedure or surgery
Subjects will be given weekly pharyngo-esophageal stimulation guided by high resolution impedance manometry for 4 weeks. During this time of study intervention, every feed will start with nutritive oral stimulation with at least 5 mL of the infant's prescribed diet.
| Study group | Role | What they receive |
|---|---|---|
| Infants with Complex Feeding Difficulties | Experimental | Weekly manometric esophageal stimulation as well as consistent nutritive oral feeding therapy Receives: Procedure: Esophageal stimulation with high resolution esophageal manometry and nutritive oral feeding therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oral feeding volumes prior to and at the completion of the study
Oral feeding volume will be compared prior to the initial manometry study and after the completion of the final manometry study after 4 weeks or prior to discharge, whichever is earliest
Measured: Collected at 4 weeks or prior to discharge
Parent surveys
Parental questionnaires will be compared from prior to initial esophageal manometry study and after completion of final esophageal manometry study.
Measured: 4 weeks or prior to discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start5 Feb 2024
- Primary completion1 Nov 2028 (estimated)
- Study completion1 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Feeding Disorder NeonatalStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Mechanistic study design
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sudarshan Jadcherla
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sudarshan Jadcherla, Nationwide Children's Hospital
- Investigators
- Sudarshan Jadcherla, Principal investigator, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06118697
- Sponsor's protocol ID
- STUDY00000804
- Acronym
- FAST
- Status last verified
- Apr 2026
- First submitted
- 26 Oct 2023
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: will revisit at a later date
Publications
Jadcherla SR, Helmick R, Osborn EK, Alshaikh ES. Safety and feasibility of a novel oesophageal stimulation protocol in modulating aerodigestive mechanisms and outcomes in infants at-risk for gastrostomy: a pilot study. EClinicalMedicine. 2026 Aug 5;98:104128. doi: 10.1016/j.eclinm.2026.104128. eCollection 2026 Aug.
PubMed 42598464
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Feasibility of Aerodigestive Stimulation Therapy in Infants With Complex Feeding Difficulties
- ClinicalTrials.gov ID
- NCT06118697
- Acronym / sponsor ID
- FAST / STUDY00000804
- Conditions
- Feeding Disorder Neonatal
- Keywords
- Chronic tube feeding, Gastrostomy, Deglutition, Esophageal manometry
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Sudarshan JadcherlaUniversity, hospital or other
- Study start
- 5 Feb 2024 (actual)
- Primary completion
- 1 Nov 2028 (estimated)
- Study completion
- 1 Nov 2028 (estimated)
- First posted
- 7 Nov 2023 (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.
The goal of this study is to demonstrate safety, feasibility, and efficacy of a novel pharyngo-esophageal stimulation technique in restoring aerodigestive and swallowing functions in select infants at-risk for chronic gavage tube feeding or gastrostomy. The main aims are:
- To provide consistent activation of deglutition (the process of swallowing), swallowing-airway interactions, and peristalsis in order to decrease the risk of home tube feeding.
- To examine whether physical and manometric evidence-guided interventions and biofeedback will improve compliance, minimize parental stress, and increase satisfaction and perceived self-confidence with infant feeding.
Participants will have weekly pharyngo-esophageal stimulation guided by High Resolution Impedance Manometry (HRIM) for 4 weeks or until discharge, oral nutritive stimulation of at least 5 mL of prescribed milk with each feed, and weekly parental education and feedback regarding feeding progress.
Detailed description
Stimulation will be provided to the esophagus using esophageal manometry starting at enrollment and then weekly for 4 weeks or until discharge, whichever occurs first. During the 4 weeks of study enrollment, subjects will also be provided nutritive oral feeding therapy with each care with a minimum of 5 mL of their prescribed feed. Feeding evaluations by a study team member will occur once a day during the length of the 4-week trial. The study team will do weekly rounds at the bedside to evaluate feeding progress and study interventions. A feeding plan will be posted at the bedside for clear communication with the care team and family of the subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Mechanistic study design
| Arm | Type | Receives |
|---|---|---|
| Infants with Complex Feeding Difficulties | Experimental | Procedure: Esophageal stimulation with high resolution esophageal manometry and nutritive oral feeding therapyWeekly manometric esophageal stimulation as well as consistent nutritive oral feeding therapy |
Who may qualify
- Ages
- 1 day to 8 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- NICU infant ≥37 weeks postmenstrual age not taking full oral feeds
- Consult to Neonatal \& Infant Feeding Disorder Program for oral feeding difficulty with diagnostic manometry ordered
- Presence of peristaltic and sphincteric reflexes at initial manometry
Key exclusion criteria (3 listed)
- Potentially lethal chromosomal anomalies
- Craniofacial malformations
- Foregut malformations
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 |
|---|---|---|
| Esophageal stimulation with high resolution esophageal manometry and nutritive oral feeding therapySubjects will be given weekly pharyngo-esophageal stimulation guided by high resolution impedance manometry for 4 weeks. During this time of study intervention, every feed will start with nutritive oral stimulation with at least 5 mL of the infant's prescribed diet. | Procedure or surgery | Infants with Complex Feeding Difficulties |
Primary outcome
Oral feeding volumes prior to and at the completion of the study
Time frame: Collected at 4 weeks or prior to discharge
Oral feeding volume will be compared prior to the initial manometry study and after the completion of the final manometry study after 4 weeks or prior to discharge, whichever is earliest
Parent surveys
Time frame: 4 weeks or prior to discharge
Parental questionnaires will be compared from prior to initial esophageal manometry study and after completion of final esophageal manometry study.
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 5 May 2026.
- Derived from this study: PubMed 42598464Jadcherla SR, Helmick R, Osborn EK, Alshaikh ES. Safety and feasibility of a novel oesophageal stimulation protocol in modulating aerodigestive mechanisms and outcomes in infants at-risk for gastrostomy: a pilot study. EClinicalMedicine. 2026 Aug 5;98:104128. doi: 10.1016/j.eclinm.2026.104128. eCollection 2026 Aug.
- Individual participant dataSharing planned: No. will revisit at a later date
Related trials for Feeding Disorder Neonatal
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Odevixibat Pregnancy and Lactation Surveillance Program: A Study to Evaluate the Safety of Odevixibat During Pregnancy and/or Lactation
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Parent-Facilitated Early Oral-Sensory Experience in the NICU for Feeding Outcomes
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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.
Sudarshan Jadcherla principal investigator
Nationwide Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Esophageal stimulation with high resolution esophageal manometry and nutritive oral feeding therapy in people with Feeding Disorder Neonatal, run by Sudarshan Jadcherla 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 3 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: looking for participants now, as of the sponsor's last update on 5 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?
Contact Erika K Osborn (6143556667, erika.osborn@nationwidechildrens.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oral feeding volumes prior to and at the completion of the study (time frame: Collected at 4 weeks or prior to discharge). 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 NCT06118697, which also lists 1 linked publication.
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 5 May 2026.