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| Name | Class |
|---|---|
| Children's Healthcare of Atlanta | OTHER |
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The primary objective of this study is to determine to what extent hunger provocation, via rapid weaning from enteral feedings, is acceptable and feasible and to evaluate the effect of this intervention when used in an intensive multidisciplinary feeding intervention (IMFI) model of treatment (standard care), for individuals with Avoidant Food Intake Disorder (ARFID) who are dependent on enteral feedings to meet their daily caloric needs.
The recognized standard of care for children dependent on feeding tubes is intensive multidisciplinary feeding intervention (IMFI) involving a professional team that includes psychologists, physicians, nurse practitioners, registered dietitian nutritionists, and speech-language pathologists/occupational therapists working together in inpatient or day hospital settings. A meta-analysis of 11 studies involving intensive, multidisciplinary intervention reported that 71% (95% CI, 54%-83%) of 454 patients successfully weaned from feeding tube dependence at discharge from inpatient or intensive day treatment programs. Treatment gains were maintained following discharge, with 80% (95% CI, 66%-89%) of 414 patients successfully weaned from tube feedings at last follow-up. The most common treatment approaches documented by the meta-analysis involved behavioral intervention and tube weaning (hunger manipulation - evoking a state of hunger to encourage oral consumption by rapidly weaning from the tube). The review highlighted the lack of consensus among clinicians and researchers regarding the criteria for, rate of, and timing of weaning from enteral feedings.
As a result, the authors concluded that the relative contribution of aggressive tube weaning as a standalone or adjunctive therapy to behavioral intervention remains uncertain.
The primary objective of this study is to determine to what extent hunger provocation, via rapid weaning from enteral feedings, is acceptable and feasible and to evaluate the effect of this intervention when used as an adjunct to our standard model of behavioral intervention within the study team's IMFI program, for individuals with Avoidant Food Intake Disorder (ARFID) who are dependent on enteral feedings to meet their daily caloric needs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intensive Multidisciplinary Intervention (Standard Care) | Active Comparator | Children with a history of chronic food refusal will be randomized to receive the standard of care. The standard of care for tube wean is to accomplish the balance between enteral supplementation and oral intake, the tube feeding regimen will follow the schedule of therapeutic meals (e.g., mid-day supplementation occurs after morning therapeutic meals). |
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| Intensive Multidisciplinary Intervention (Standard Care) + Hunger provocation (Rapid Tube Wean) | Experimental | Children with a history of chronic food refusal will be randomized to receive the experimental arm that combines standard care with rapid tube wean. All schedules and documents will be updated accordingly. After the 50% tube wean cut, the dietitian will use regular tube wean sheet to provide credit for oral intake for remainder of admission. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intensive Multidisciplinary Feeding Intervention (IMFI)-Standard of Care | Behavioral | Standard care involves behavioral intervention delivered during admission Intensive Multidisciplinary Intervention. Patients admitted to the program will participate in four therapeutic meals per day, five days per week (Monday through Friday). The behavioral intervention involves a standard sequence of reinforcement techniques, bite persistence (a.k.a., contingency contacting, escape extinction), and stimulus fading/antecedent manipulation protocols. Parent training will be the central method for structuring meals and transferring treatment gains from the clinic to the home setting. The sequence and steps for parents training will follow a sequential, proficiency-based process, with caregivers transitioning to serve as the primary feeder by discharge. Management of tube wean in our standard of care involves reducing tube feeding calories based on oral intake at a 1:1 ratio. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Percentage of oral intake | The percent oral intake will be calculated by dividing calories consumed during therapeutic meals by the daily calorie target. | Up to 12 months |
| Percent of patients achieving full wean and time to full wean | % of participants reaching 100% of their caloric needs by mouth | Measured in days with a time frame of up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in weight and BMI | Weight will be measured in kilograms (Kg) on a digital scale; height measured in cm; BMI calculated from weight and height into kg/m2, z-score, and percentile | Up to 12 months |
| Mealtime performance. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Valerie Volket, PhD, BCBA-D | Emory -Children's Ped Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Advanced Pediatrics | Atlanta | Georgia | 30329 | United States | ||
| Marcus Autism Center |
Access to deidentified research data.
Immediately after publication.
The researchers will share the data with anyone who wishes to access the data for any purpose.
Proposals should be addressed to Dr. Volkert. To gain access, data requestors will need to sign a data access agreement. Data will available for 5 years.
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Participants will be randomized 1:1 to intensive feeding intervention (standard care) or intensive feeding intervention (standard care) + rapid tube weaning study groups using permuted blocks of size 2 or 4.
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The allocation pattern is concealed to the investigators and therapists providing intervention.
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| Intensive Multidisciplinary Feeding Intervention (IMFI) standard of care + rapid tube weaning | Behavioral | The experimental arm combines standard care with a rapid tube wean. On day 1, the dietitian will meet with the caregiver to determine the usual tube feeding schedule. The dietitian will then create a tube feeding plan that meets 70% of the child's caloric needs (a 30% reduction).On day 3, if a patient has moved past a rice size bite volume in therapeutic meals, the patient's tube feedings will be further reduced to meet 50% of needs. All schedules and documents will be updated accordingly. After the 50% tube wean cut, the dietitian will use a regular tube wean sheet to provide credit for oral intake for the remainder of admission. |
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Bite acceptance, rapid swallowing, and inappropriate mealtime behavior
| Up to 12 months |
| Atlanta |
| Georgia |
| 30329 |
| United States |
| ID | Term |
|---|---|
| D001068 | Feeding and Eating Disorders |
| D000080146 | Avoidant Restrictive Food Intake Disorder |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| D009752 | Nutritional Status |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D006304 | Health Status |
| D003710 | Demography |
| D011154 | Population Characteristics |
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