Feeding Disorders
Conditions
Brief summary
The investigators are conducting a 16 week multiple cross-over study (N-of-1 trial) comparing two blenderized tube feeds varying in viscosity in 40 children.
Interventions
OTHERExtremely thick blenderized tube feed
Commercial blenderized tube feed, not diluted
OTHERMildly thick blenderized tube feed
Commercial blenderized tube feed, diluted with ingredients contained in blend
Sponsors
Boston Children's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* age \> 1 year * \>90% of total calories via G-tube for \> 6 months * G-tube diameter ≥ 14 French * moderate severity of upper GI symptoms of nausea, bloating, postprandial fullness and early satiety defined as Gastroparesis Cardinal Symptom Index-Daily Diary (GCSI-DD) composite score \> 2 * anticipated stable GI-related medications for the duration of the study.
Exclusion criteria
* cystic fibrosis, primary ciliary dyskinesia, interstitial lung disease, bronchiolitis obliterans, or lung transplant * untreated malabsorptive intestinal disease (e.g. Crohn's disease, celiac disease) * Nissen fundoplication * use of non-standard enteral formulas (e.g. ketogenic formulas) for the management of metabolic, endocrine or neurologic rare diseases * allergy or intolerance to any component of the study diet * inability to tolerate bolus gastric feeds.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Upper GI symptoms | 8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design) | differences in daily parental rating of upper gastrointestinal symptoms from the validated Gastroparesis Cardinal Symptom Index-Daily Diary (GCSI-DD) between extremely and mildly thick blenderized tube feeds |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gastrointestinal symptoms | 8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design) | Pediatric Quality of Life Inventory (PedsQL) Gastrointestinal Symptoms Questionnaire, scale of 0 to 100, higher scores indicate less symptom burden |
| Pulmonary symptoms | 8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design) | Pediatric Cough Questionnaire, score ranges from 0 to 25, higher scores indicate less symptom burden |
| Health care utilization | 8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design) | frequency of hospital admissions |
| GI medication use | 8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design) | % of participants requiring acid suppressive medication or GI motility agents such as cyproheptadine and erythromycin |
| Height | 8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design) | height |
| Weight | 8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design) | Weight or weight for length |
| Weight for height/body mass index (BMI) | 8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design) | weight for height (children \< 2) or BMI (over 2 years of age) |
| number of patients with unplanned G-tube exchange | 8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design) | — |
| urine output adequacy | 8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design) | frequency of urine output |
| rate of respiratory suctioning per day | 8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design) | how often suctioning is required (e.g. number of times per day) |
| need for antibiotics for pneumonitis | 8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design) | frequency of antibiotics prescribed for pulmonary indications |
Countries
United States
Outcome results
None listed