Airway Aspiration, Airway Penetration, Dysphagia
Conditions
Keywords
Infant, Feeding difficulties, Dysphagia
Brief 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 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.
Interventions
DIAGNOSTIC_TESTCombined testing (diagnostic VFSS + research HRM) + Parent Preferred Therapy
Addition of research HRM along with diagnostic VFSS with parental choice of therapy
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Ohio State University
Medical College of Wisconsin
Sudarshan Jadcherla
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
38 Weeks to 60 Weeks
Healthy volunteers
No
Inclusion criteria
* 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)
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Successful Safe Oral Feeding | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Weight Growth Velocity in Grams/Day | 4 weeks | 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. |
| Hospital Length of Stay From Admission to Discharge in Days | from hospital admission until discharge | The investigators will track the subjects length of hospitalization which included their initial study procedure. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Study Eligible subjects (study) will undergo diagnostic VFSS in combination with manometry, either concurrent or sequential. They will have parental choice of preferred feeding therapy.
Combined Diagnostic testing (VFSS + HRM) + Parent Preferred Therapy: HRM along with diagnostic VFSS with parental choice of therapy | 60 |
| Control Eligible subjects who had VFSS alone with provider recommendations from the same single center. | 49 |
| Total | 109 |
Baseline characteristics
| Characteristic | Control | Total | Study |
|---|---|---|---|
| Age, Categorical <=18 years | 49 Participants | 109 Participants | 60 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 45.7 weeks | 45.7 weeks | 45.7 weeks |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 15 Participants | 24 Participants | 9 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 31 Participants | 81 Participants | 50 Participants |
| Region of Enrollment United States | 49 participants | 109 participants | 60 participants |
| Sex: Female, Male Female | 30 Participants | 56 Participants | 26 Participants |
| Sex: Female, Male Male | 19 Participants | 53 Participants | 34 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 60 | 0 / 49 |
| other Total, other adverse events | 0 / 60 | 0 / 49 |
| serious Total, serious adverse events | 0 / 60 | 0 / 49 |
Outcome results
Primary
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
Time frame: Up to 4 weeks after enrollment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Study | Number of Participants With Successful Safe Oral Feeding | 51 Participants |
| Control | Number of Participants With Successful Safe Oral Feeding | 31 Participants |
p-value: 0.008Chi-squared
Secondary
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.
Time frame: from hospital admission until discharge
Population: Some patients in study group were outpatient
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Study | Hospital Length of Stay From Admission to Discharge in Days | 43.6 days | Standard Deviation 49.7 |
| Control | Hospital Length of Stay From Admission to Discharge in Days | 49.9 days | Standard Deviation 58.4 |
p-value: 0.592t-test, 2 sided
Secondary
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.
Time frame: 4 weeks
Population: Unable to get growth velocity on all patients as they were not all hospitalized or weight at 4 weeks after study
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Study | Weight Growth Velocity in Grams/Day | 27 grams/day | Standard Deviation 11.1 |
| Control | Weight Growth Velocity in Grams/Day | 26.7 grams/day | Standard Deviation 11.5 |
p-value: 0.907t-test, 2 sided