Spectral Lighting and Intestinal Failure
- Conditions
- Intestinal Failure
- Interventions
- Other: Spectral Lighting
- Registration Number
- NCT06094504
- Lead Sponsor
- Children's Hospital Medical Center, Cincinnati
- Brief Summary
The goal of this exploratory n-of-1-study is to compare markers of metabolism in infants with intestinal failure between two lighting environments. Investigators are seeking to learn whether supplementing the lighting environment of infants with intestinal failure with blue and violet wavelengths of light will allow more efficient utilization of the nutrition provided to participants by influencing hormones involved in regulation of growth and development as compared to a conventional lighting environment.
Pre-clinical studies suggest that violet and blue wavelengths of light are involved in molecular pathways that help regulate metabolic activity.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 32
- greater than or equal to 32 weeks post-menstrual age (PMA)
- diagnosis or anticipated diagnosis of intestinal failure by qualified provider
- have an anticipated hospital stay of at least 5 weeks following initiation of study participation
- Infants with major congenital anomalies outside of the gastrointestinal tract
- Infants with aneuploidy (having an abnormal amount of chromosomes)
- Infants <32 weeks post-menstrual age (PMA)
- Infants who are anticipated to require a major surgery after enrollment other than anastomosis.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Lighting cycling (Spectral vs Conventional) Spectral Lighting A washout period of one week will commence the Monday after study subject enrollment, followed by four weeks of alternating periods of 3 days of daytime full spectrum lighting (FS) including violet and blue light wavelengths and 4 days of daytime conventional (CON) hospital lighting.
- Primary Outcome Measures
Name Time Method plasma protein concentration of insulin For four weeks, once a week for each lighting condition and once a week during the predawn hours after each lighting condition, for a total of four samples per week. Protein concentrations of plasma insulin as analyzed by SomaScan large scale proteomics assay will be compared among plasma samples taken in lighting conditions and between each lighting condition and dark.
plasma protein concentration of leptin For four weeks, once a week for each lighting condition and once a week during the predawn hours after each lighting condition, for a total of four samples per week. Protein concentrations of plasma insulin as analyzed by SomaScan large scale proteomics assay will be compared among plasma samples taken in lighting conditions and between each lighting condition and dark.
- Secondary Outcome Measures
Name Time Method Creatinine Typically collected twice-weekly for the duration of the participant's 4-week study timeline creatinine concentration in mg/dL
Albumin Typically collected twice-weekly for the duration of the participant's 4-week study timeline albumin concentration in gm/dL
temperature For the duration of the participant's 4-week study timeline body temperature as measured throughout the day, usually every 3-4 hrs
heart rate For the duration of the participant's 4-week study timeline heart rate throughout the day, as collected every 3-4 hrs
Phosphorus concentration Typically collected twice-weekly for the duration of the participant's 4-week study timeline concentration of Phosphorus in serum (mg/dL)
Magnesium concentration Typically collected twice-weekly for the duration of the participant's 4-week study timeline concentration of Magnesium in serum (mg/dL)
Calcium concentration Typically collected twice-weekly for the duration of the participant's 4-week study timeline concentration of Calcium in serum (mg/dL)
Sodium concentration Typically collected twice-weekly for the duration of the participant's 4-week study timeline concentration of Sodium in serum (mmol/L)
Potassium concentration Typically collected twice-weekly for the duration of the participant's 4-week study timeline concentration of Potassium in serum (mmol/L)
Chloride concentration Typically collected twice-weekly for the duration of the participant's 4-week study timeline concentration of Chloride in serum (mmol/L)
glucose Typically collected twice-weekly for the duration of the participant's 4-week study timeline glucose concentration in mg/dL
Blood Urea Nitrogen Typically collected twice-weekly for the duration of the participant's 4-week study timeline blood urea nitrogen concentration in mg/dL
Total protein level Typically collected twice-weekly for the duration of the participant's 4-week study timeline total protein concentration in gm/dL
Alanine Aminotransferase (ALT) Typically collected twice-weekly for the duration of the participant's 4-week study timeline Alanine Aminotransferase concentration in unit/L
Aspartate Aminotransferase (AST) Typically collected twice-weekly for the duration of the participant's 4-week study timeline Aspartate Aminotransferase (AST) concentration in unit/L
Alkaline Phosphatase (ALP) Typically collected twice-weekly for the duration of the participant's 4-week study timeline Alkaline Phosphatase (ALP) concentration in unit/L
Triglyceride Typically collected twice-weekly for the duration of the participant's 4-week study timeline Triglyceride concentration in mg/dL
Gamma Glutamyl Transferase (GGT) Typically collected twice-weekly for the duration of the participant's 4-week study timeline Gamma Glutamyl Transferase (GGT) concentration in unit/L
Total Bilirubin Typically collected twice-weekly for the duration of the participant's 4-week study timeline Total Bilirubin concentration in mg/dL
Direct Bilirubin Typically collected twice-weekly for the duration of the participant's 4-week study timeline Direct Bilirubin concentration in mg/dL
Trial Locations
- Locations (1)
Cincinnati Children's Hospital Medical Center
🇺🇸Cincinnati, Ohio, United States