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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Commercial blenderized tube feed, not diluted
Commercial blenderized tube feed, diluted with ingredients contained in blend
Boston Children's Hospital
Boston, Massachusetts, United States
RECRUITINGUpper GI symptoms
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
Time frame: 8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design)
Gastrointestinal symptoms
Pediatric Quality of Life Inventory (PedsQL) Gastrointestinal Symptoms Questionnaire, scale of 0 to 100, higher scores indicate less symptom burden
Time frame: 8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design)
Gastrointestinal symptoms
Pediatric Quality of Life Inventory Gastroparesis Questionnaire, , scale of 0 to 100, higher scores indicate less symptom burden
Time frame: 8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design)
Pulmonary symptoms
Pediatric Cough Questionnaire, score ranges from 0 to 25, higher scores indicate less symptom burden
Time frame: 8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design)
Health care utilization
frequency of hospital admissions
Time frame: 8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design)
Health care utilization
length of hospital admissions
Time frame: 8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design)
Health care utilization
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rates of ER/urgent care visits
Time frame: 8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design)
GI medication use
% of participants requiring acid suppressive medication or GI motility agents such as cyproheptadine and erythromycin
Time frame: 8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design)
Height
height
Time frame: 8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design)
Weight
Weight or weight for length
Time frame: 8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design)
Weight for height/body mass index (BMI)
weight for height (children \< 2) or BMI (over 2 years of age)
Time frame: 8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design)
number of patients with unplanned G-tube exchange
Time frame: 8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design)
urine output adequacy
frequency of urine output
Time frame: 8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design)
rate of respiratory suctioning per day
how often suctioning is required (e.g. number of times per day)
Time frame: 8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design)
need for antibiotics for pneumonitis
frequency of antibiotics prescribed for pulmonary indications
Time frame: 8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design)