Spectral Lighting and Intestinal Failure

Study Overview
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Brief Summary
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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.

Official Title
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Impact of Full Spectrum Light on Outcomes of Infants With Intestinal Failure

Conditions
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Intestinal Failure

Intervention / Treatment
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* Other: Spectral Lighting


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: greater than or equal to 32 weeks gestational age diagnosis or anticipated diagnosis of intestinal failure by qualified provider Infants <32 weeks gestation have an anticipated hospital stay of at least 9 weeks following initiation of study participation Exclusion Criteria: Infants with major congenital anomalies outside of the gastrointestinal tract Infants with aneuploidy (having an abnormal amount of chromosomes) Infants <32 weeks gestation Infants who are anticipated to require a major surgery after enrollment.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Interventional Model Description: N-of-1 study design in which each subject will serve as their own control.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lighting cycling (Spectral vs Conventional)<br>A washout period of one week will commence the Monday after study subject enrollment, followed by 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. | Other: Spectral Lighting<br>* Spectral room lighting containing violet and blue wavelengths of light capable of stimulating non-visual opsins including OPN5 and OPN3.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| plasma protein concentration of insulin | 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. | From one week into enrollment through week 5, once a week for each lighting condition and twice each . Plasma from weeks 6-9 will be saved in a biobank for potential future proteomic analysis. | 
| plasma protein concentration of leptin | 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. | From one week into enrollment through week 5, once a week for each lighting condition and twice each . Plasma from weeks 6-9 will be saved in a biobank for potential future proteomic analysis. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| temperature | body temperature as measured throughout the day, usually every 3-4 hrs | For the duration of the participant's 9-week study timeline | 
| heart rate | heart rate throughout the day, as collected every 3-4 hrs | For the duration of the participant's 9-week study timeline | 
| Phosphorus concentration | concentration of Phosphorus in serum (mg/dL) | Typically collected twice-weekly for the duration of the participant's 9-week study timeline | 
| Magnesium concentration | concentration of Magnesium in serum (mg/dL) | Typically collected twice-weekly for the duration of the participant's 9-week study timeline | 
| Calcium concentration | concentration of Calcium in serum (mg/dL) | Typically collected twice-weekly for the duration of the participant's 9-week study timeline | 
| Sodium concentration | concentration of Sodium in serum (mmol/L) | Typically collected twice-weekly for the duration of the participant's 9-week study timeline | 
| Potassium concentration | concentration of Potassium in serum (mmol/L) | Typically collected twice-weekly for the duration of the participant's 9-week study timeline | 
| Chloride concentration | concentration of Chloride in serum (mmol/L) | Typically collected twice-weekly for the duration of the participant's 9-week study timeline | 
| glucose | glucose concentration in mg/dL | Typically collected twice-weekly for the duration of the participant's 9-week study timeline | 
| Blood Urea Nitrogen | blood urea nitrogen concentration in mg/dL | Typically collected twice-weekly for the duration of the participant's 9-week study timeline | 
| Creatinine | creatinine concentration in mg/dL | Typically collected twice-weekly for the duration of the participant's 9-week study timeline | 
| Albumin | albumin concentration in gm/dL | Typically collected twice-weekly for the duration of the participant's 9-week study timeline | 
| Total protein level | total protein concentration in gm/dL | Typically collected twice-weekly for the duration of the participant's 9-week study timeline | 
| Alanine Aminotransferase (ALT) | Alanine Aminotransferase concentration in unit/L | Typically collected twice-weekly for the duration of the participant's 9-week study timeline | 
| Aspartate Aminotransferase (AST) | Aspartate Aminotransferase (AST) concentration in unit/L | Typically collected twice-weekly for the duration of the participant's 9-week study timeline | 
| Alkaline Phosphatase (ALP) | Alkaline Phosphatase (ALP) concentration in unit/L | Typically collected twice-weekly for the duration of the participant's 9-week study timeline | 
| Gamma Glutamyl Transferase (GGT) | Gamma Glutamyl Transferase (GGT) concentration in unit/L | Typically collected twice-weekly for the duration of the participant's 9-week study timeline | 
| Triglyceride | Triglyceride concentration in mg/dL | Typically collected twice-weekly for the duration of the participant's 9-week study timeline | 
| Total Bilirubin | Total Bilirubin concentration in mg/dL | Typically collected twice-weekly for the duration of the participant's 9-week study timeline | 
| Direct Bilirubin | Direct Bilirubin concentration in mg/dL | Typically collected twice-weekly for the duration of the participant's 9-week study timeline |