DysphagiaNCT02583360
Mechanisms and Management of Infant Dysphagia
A study testing Combined testing (diagnostic VFSS + research HRM) + Parent Preferred Therapy in people with Dysphagia and Airway Aspiration, run by Sudarshan Jadcherla at 1 site in United States.
Trial summary
The purpose of the investigator's study is to evaluate the causes of feeding difficulty in infants. New treatments can be possible only if the cause is known. In this study, the investigator plans to evaluate the movement of the muscles in an infant's mouth, throat (pharynx) and food pipe (esophagus) that are… Read more about this study
- Who is it for?
- Ages 38 to 60 weeks
- Conditions the study is for
- Dysphagia, Airway Aspiration, Airway Penetration
- What is being tested?
- Combined testing (diagnostic VFSS + research HRM) + Parent Preferred Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 109 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Oct 2015to 30 Aug 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 38 to 60 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants with feeding-related aero-digestive symptoms
- ≤60 weeks PMA (both pre-term and full term)
- History of orally feeding ≥ 25% of least 50% of prescribed feeding volume
- Room air or supplemental oxygen of ≤1liter/minute (LPM)
Who cannot join
- Direct breast feeding exclusively
- Known genetic, metabolic or syndromic disease
- Neurological diseases such as Grade 3 or 4 intraventricular hemorrhage (IVH) or intracranial hemorrhage (ICH), moderate to severe perinatal asphyxia or stroke
- Craniofacial, airway or foregut malformations
- History of craniofacial, foregut, ears, nose and throat (ENT) or neurosurgery
Trial locations and contacts
1 site in 1 country.
United States1 site
The Research Institute at Nationwide Children's Hospital
Columbus, Ohio, 43205
About this study
Official title: Neonatal Esophagus and Airway Interactions in Health and Disease
The purpose of the investigator's study is to evaluate the causes of feeding difficulty in infants. New treatments can be possible only if the cause is known. In this study, the investigator plans to evaluate the movement of the muscles in an infant's mouth, throat (pharynx) and food pipe (esophagus) that are responsible for moving the food down into the stomach and that help protect an infants airway.
Read the detailed description
Infants with chronic feeding difficulties exhibit inadequacy of suck-swallow and breathe coordination, regurgitation or vomiting, gastroesophageal reflux disease, and airway aspiration. Often these infants must rely on feeding tubes, either inserted through the nose or surgically placed, to meet their nutrition and hydration needs until they are able to orally feed safely, effectively, and efficiently. The process of assessment and treatment of swallowing disorders is often stressful for the infants and their providers, including parents. The goal of this study is to combine two commonly used diagnostic techniques (video fluoroscopy swallow studies and esophageal manometry) to more comprehensively evaluate feeding from the mouth to the stomach in infants. The hope is that by doing so treatment strategies can be improved.
: Eligible subjects (study) will undergo diagnostic VFSS in combination with manometry, either concurrent or sequential. They will have parental choice of preferred feeding therapy. The data is from single center prospective observational study. The controls are those who had VFSS alone with provider recommendations from the same single center.
In addition, we are also embarking on alternate strategies to achieve the original stated aims: 1) Mechanisms of dysphagia is ascertained by studying concurrent recordings of VFSS and manometry. 2) Feeding outcomes of Dysphagic infants are ascertained by evaluating the discharge outcomes and 1-year feeding outcomes among those that had evaluation of dysphagia using VFSS. 3) Dysphagic infants that had sequential VFSS and manometry studies are evaluated to test which method is a better predictor of stated outcomes.
- Conditions
- Dysphagia, Airway Aspiration, Airway Penetration
- Being tested
- Combined testing (diagnostic VFSS + research HRM) + Parent Preferred Therapy
- Keywords
- Infant, Feeding difficulties, Dysphagia
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined testing (diagnostic VFSS + research HRM) + Parent Preferred TherapyDiagnostic test
Addition of research HRM along with diagnostic VFSS with parental choice of therapy
| Study group | Role | What they receive |
|---|---|---|
| Study | Active comparator | Eligible subjects (study) will undergo diagnostic VFSS in combination with manometry, either concurrent or sequential. They will have parental choice of preferred feeding therapy. Receives: Diagnostic Test: Combined testing (diagnostic VFSS + research HRM) + Parent Preferred Therapy |
| Control | No intervention | Eligible subjects who had VFSS alone with provider recommendations from the same single center. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Successful Safe Oral Feeding
The primary endpoint is the feeding success defined as full oral feeding (no tube feeds feeds) without symptoms that require interventions
Measured: Up to 4 weeks after enrollment
Secondary outcomes (2)
Weight Growth Velocity in Grams/Day
The investigators will measure and track growth velocity (grams/day) during this time period. This will be completed through chart reviews of weight from subsequent clinic visits and parent interviews.
Measured: 4 weeks
Hospital Length of Stay From Admission to Discharge in Days
The investigators will track the subjects length of hospitalization which included their initial study procedure.
Measured: from hospital admission until discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2015 (estimated)
- Study start2 Oct 2015
- Primary completion30 Aug 2020
- Study completion30 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for DysphagiaStudies 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Eligible consented subjects (study) from a single center will undergo standard of care diagnostic VFSS in combination with the research intervention of utilizing manometry procedures to measure pharyngo-esophageal motility to aid with precise diagnosis, either concurrent or sequential. They will then have parental choice of preferred feeding therapy based on combined testing methods rather than therapy being prescribed by the VFSS results. The controls are those who had VFSS alone (standard of care) with treatment based solely on VFSS guided provider recommendations from the same single center.
- Masking
- None (open label)
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sudarshan Jadcherla
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Ohio State University, Medical College of Wisconsin
- Responsible party
- Sponsor-investigator, Sudarshan Jadcherla, Nationwide Children's Hospital
- Investigators
- Sudarshan R Jadcherla, MD, Principal investigator, Nationwide Children's HospitalReza Shaker, MD, Study chair, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02583360
- Sponsor's protocol ID
- 14-00794
- Other IDs
- P01DK068051
- Status last verified
- Aug 2021
- First submitted
- 20 Oct 2015
- Last updated
- 23 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jadcherla SR, Stoner E, Gupta A, Bates DG, Fernandez S, Di Lorenzo C, Linscheid T. Evaluation and management of neonatal dysphagia: impact of pharyngoesophageal motility studies and multidisciplinary feeding strategy. J Pediatr Gastroenterol Nutr. 2009 Feb;48(2):186-92. doi: 10.1097/MPG.0b013e3181752ce7.
PubMed 19179881Jadcherla SR, Peng J, Moore R, Saavedra J, Shepherd E, Fernandez S, Erdman SH, DiLorenzo C. Impact of personalized feeding program in 100 NICU infants: pathophysiology-based approach for better outcomes. J Pediatr Gastroenterol Nutr. 2012 Jan;54(1):62-70. doi: 10.1097/MPG.0b013e3182288766.
PubMed 21694638Jadcherla SR, Gupta A, Stoner E, Fernandez S, Shaker R. Pharyngeal swallowing: defining pharyngeal and upper esophageal sphincter relationships in human neonates. J Pediatr. 2007 Dec;151(6):597-603. doi: 10.1016/j.jpeds.2007.04.042. Epub 2007 Aug 23.
PubMed 18035137Jadcherla SR, Shubert TR, Gulati IK, Jensen PS, Wei L, Shaker R. Upper and lower esophageal sphincter kinetics are modified during maturation: effect of pharyngeal stimulus in premature infants. Pediatr Res. 2015 Jan;77(1-1):99-106. doi: 10.1038/pr.2014.147. Epub 2014 Oct 3.
PubMed 25279989
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neonatal Esophagus and Airway Interactions in Health and Disease
- ClinicalTrials.gov ID
- NCT02583360
- Acronym / sponsor ID
- 14-00794
- Conditions
- Dysphagia, Airway Aspiration, Airway Penetration
- Keywords
- Infant, Feeding difficulties, Dysphagia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Sudarshan JadcherlaUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Ohio State University, Medical College of Wisconsin
- Study start
- 2 Oct 2015 (actual)
- Primary completion
- 30 Aug 2020 (actual)
- Study completion
- 30 Aug 2020 (actual)
- First posted
- 22 Oct 2015 (estimated)
- Results
- Posted 16 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the investigator's study is to evaluate the causes of feeding difficulty in infants. New treatments can be possible only if the cause is known. In this study, the investigator plans to evaluate the movement of the muscles in an infant's mouth, throat (pharynx) and food pipe (esophagus) that are responsible for moving the food down into the stomach and that help protect an infants airway.
Detailed description
Infants with chronic feeding difficulties exhibit inadequacy of suck-swallow and breathe coordination, regurgitation or vomiting, gastroesophageal reflux disease, and airway aspiration. Often these infants must rely on feeding tubes, either inserted through the nose or surgically placed, to meet their nutrition and hydration needs until they are able to orally feed safely, effectively, and efficiently. The process of assessment and treatment of swallowing disorders is often stressful for the infants and their providers, including parents. The goal of this study is to combine two commonly used diagnostic techniques (video fluoroscopy swallow studies and esophageal manometry) to more comprehensively evaluate feeding from the mouth to the stomach in infants. The hope is that by doing so treatment strategies can be improved.
: Eligible subjects (study) will undergo diagnostic VFSS in combination with manometry, either concurrent or sequential. They will have parental choice of preferred feeding therapy. The data is from single center prospective observational study. The controls are those who had VFSS alone with provider recommendations from the same single center.
In addition, we are also embarking on alternate strategies to achieve the original stated aims: 1) Mechanisms of dysphagia is ascertained by studying concurrent recordings of VFSS and manometry. 2) Feeding outcomes of Dysphagic infants are ascertained by evaluating the discharge outcomes and 1-year feeding outcomes among those that had evaluation of dysphagia using VFSS. 3) Dysphagic infants that had sequential VFSS and manometry studies are evaluated to test which method is a better predictor of stated outcomes.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Eligible consented subjects (study) from a single center will undergo standard of care diagnostic VFSS in combination with the research intervention of utilizing manometry procedures to measure pharyngo-esophageal motility to aid with precise diagnosis, either concurrent or sequential. They will then have parental choice of preferred feeding therapy based on combined testing methods rather than therapy being prescribed by the VFSS results. The controls are those who had VFSS alone (standard of care) with treatment based solely on VFSS guided provider recommendations from the same single center.
| Arm | Type | Receives |
|---|---|---|
| Study | Active comparator | Diagnostic Test: Combined testing (diagnostic VFSS + research HRM) + Parent Preferred TherapyEligible subjects (study) will undergo diagnostic VFSS in combination with manometry, either concurrent or sequential. They will have parental choice of preferred feeding therapy. |
| Control | No intervention | –Eligible subjects who had VFSS alone with provider recommendations from the same single center. |
Who may qualify
- Ages
- 38 to 60 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Infants with feeding-related aero-digestive symptoms
- ≤60 weeks PMA (both pre-term and full term)
- History of orally feeding ≥ 25% of least 50% of prescribed feeding volume
- Room air or supplemental oxygen of ≤1liter/minute (LPM)
Key exclusion criteria (5 listed)
- Direct breast feeding exclusively
- Known genetic, metabolic or syndromic disease
- Neurological diseases such as Grade 3 or 4 intraventricular hemorrhage (IVH) or intracranial hemorrhage (ICH), moderate to severe perinatal asphyxia or stroke
- Craniofacial, airway or foregut malformations
- History of craniofacial, foregut, ears, nose and throat (ENT) or neurosurgery
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 |
|---|---|---|
| Combined testing (diagnostic VFSS + research HRM) + Parent Preferred TherapyAddition of research HRM along with diagnostic VFSS with parental choice of therapy | Diagnostic test | Study |
Primary outcome
Number of Participants With Successful Safe Oral Feeding
Time frame: Up to 4 weeks after enrollment
The primary endpoint is the feeding success defined as full oral feeding (no tube feeds feeds) without symptoms that require interventions
2 secondary outcomes
Weight Growth Velocity in Grams/Day
Time frame: 4 weeks
Hospital Length of Stay From Admission to Discharge in Days
Time frame: from hospital admission until discharge
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19179881Jadcherla SR, Stoner E, Gupta A, Bates DG, Fernandez S, Di Lorenzo C, Linscheid T. Evaluation and management of neonatal dysphagia: impact of pharyngoesophageal motility studies and multidisciplinary feeding strategy. J Pediatr Gastroenterol Nutr. 2009 Feb;48(2):186-92. doi: 10.1097/MPG.0b013e3181752ce7.
- Background: PubMed 21694638Jadcherla SR, Peng J, Moore R, Saavedra J, Shepherd E, Fernandez S, Erdman SH, DiLorenzo C. Impact of personalized feeding program in 100 NICU infants: pathophysiology-based approach for better outcomes. J Pediatr Gastroenterol Nutr. 2012 Jan;54(1):62-70. doi: 10.1097/MPG.0b013e3182288766.
- Background: PubMed 18035137Jadcherla SR, Gupta A, Stoner E, Fernandez S, Shaker R. Pharyngeal swallowing: defining pharyngeal and upper esophageal sphincter relationships in human neonates. J Pediatr. 2007 Dec;151(6):597-603. doi: 10.1016/j.jpeds.2007.04.042. Epub 2007 Aug 23.
- Background: PubMed 25279989Jadcherla SR, Shubert TR, Gulati IK, Jensen PS, Wei L, Shaker R. Upper and lower esophageal sphincter kinetics are modified during maturation: effect of pharyngeal stimulus in premature infants. Pediatr Res. 2015 Jan;77(1-1):99-106. doi: 10.1038/pr.2014.147. Epub 2014 Oct 3.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Sudarshan R Jadcherla, MD principal investigator
Nationwide Children's Hospital
Reza Shaker, MD study chair
Medical College of Wisconsin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combined testing (diagnostic VFSS + research HRM) + Parent Preferred Therapy in people with Dysphagia and Airway Aspiration, 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 4 inclusion and 5 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: finished, as of the sponsor's last update on 23 Aug 2021. 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?
Yes. Results are posted in the registry (first posted 16 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Successful Safe Oral Feeding (time frame: Up to 4 weeks after enrollment). 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 NCT02583360, which also lists 4 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 23 Aug 2021.