Time Restricted Nutrition in Pediatric Stem Cell Transplant Recipients
1 other identifier
interventional
21
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2020
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 19, 2020
CompletedFirst Submitted
Initial submission to the registry
September 8, 2020
CompletedFirst Posted
Study publicly available on registry
September 16, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 25, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
November 18, 2022
CompletedFebruary 8, 2023
February 1, 2023
2.3 years
September 8, 2020
February 7, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
Number of wake episodes
Number of wake episodes
21 days
Duration of wake episodes
Duration of wake episodes
21 days
Secondary Outcomes (7)
Hypertension
21 days
Weight change
21 days
Time to tolerating oral feeds
21 days
Neutrophil engraftment
21 days
Cortisol levels
21 days
- +2 more secondary outcomes
Study Arms (2)
Cases
EXPERIMENTALPatients randomized to the cases group will receive their nutrition over a period of 12-16 hours, with minimum 8 hours of fasting and maximum 12 hours of fasting. All patients will receive 100% of their daily nutrition.
Controls
NO INTERVENTIONPatients randomized to the control group will receive the current standard of care (24-hour continuous nutrition). All patients will receive 100% of their daily nutrition.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Patients \>/= 12 months of age undergoing HSCT and receiving a myeloablative preparative regimen
You may not qualify if:
- Prior history of hypoglycemia, diabetes mellitus, metabolic disease, or other requirement for continuous nutrition
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cincinnati Children's Hospital
Cincinnati, Ohio, 45229, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christopher Dandoy
Children's Hospital Medical Center, Cincinnati
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 8, 2020
First Posted
September 16, 2020
Study Start
May 19, 2020
Primary Completion
August 25, 2022
Study Completion
November 18, 2022
Last Updated
February 8, 2023
Record last verified: 2023-02
Data Sharing
- IPD Sharing
- Will not share