Hematopoietic Stem Cell Transplant
Conditions
Brief summary
Circadian cycles, metabolism, and nutrition are intimately linked, and the timing of meals play an important role in synchronizing peripheral circadian rhythms. There are little data describing the influence of nocturnal feeds on sleep, metabolism, and overall health in hospitalized children. To evaluate this association, the investigators will conduct a single-center, randomized, non-blinded controlled trial that will test the impact of nocturnal enteral/parenteral nutrition on patient outcomes.
Detailed description
HSCT provides a potential cure for children and adults with high risk and relapsed malignancy, immune deficiency, and other fatal illnesses. Circadian cycles, metabolism, and nutrition are intimately linked, and the timing of meals play an important role in synchronizing peripheral circadian rhythms; however, the standard of care for HSCT recipients is to deliver continuous feeds (either enterally or parenterally). The objective of this study is to evaluate the influence of the timing of feeding on sleep and metabolism in HSCT subjects. The investigators hypothesize patients receiving feeds during daytime hours (0800-2000) in comparison to continuous (24 hours), will have improved sleep efficiency, decreased blood glucose, insulin, and triglycerides over patients who receive feeding overnight. The aim of this study is to evaluate the influence of the timing of feeds on sleep, metabolism, and outcomes in HSCT subjects.
Interventions
OTHER12-16 hour nutrition
Cases will receive their nutrition over a period of 12-16 hours, with minimum 8 hours of fasting and maximum 12 hours of fasting. Feeding will begin in morning hours unless otherwise directed by an investigator or registered dietician.
Sponsors
Children's Hospital Medical Center, Cincinnati
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
1:1 randomized, non-blinded, controlled
Eligibility
Sex/Gender
ALL
Age
12 Months to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients \>/= 12 months of age undergoing HSCT and receiving a myeloablative preparative regimen
Exclusion criteria
* Prior history of hypoglycemia, diabetes mellitus, metabolic disease, or other requirement for continuous nutrition
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of wake episodes | 21 days | Number of wake episodes |
| Duration of wake episodes | 21 days | Duration of wake episodes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to tolerating oral feeds | 21 days | Number of days post-transplant until the patient tolerates feeds/nutrition |
| Neutrophil engraftment | 21 days | Time to absolute neutrophil count \>500 |
| Hypertension | 21 days | Incidence of hypertension |
| Triglyceride levels | 21 days | Weekly triglyceride levels |
| Glucose levels | 21 days | Daily glucose levels |
| Cortisol levels | 21 days | 3 times weekly morning cortisol levels |
| Weight change | 21 days | Change in weight at day +7, +14, and +21 from day 0 |
Countries
United States
Outcome results
None listed