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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lighting cycling (Spectral vs Conventional) | Experimental | The study protocol will commence the Monday after study subject enrollment, if medically feasible, and will consist of four weeks of alternating periods of 3 days of daytime conventional (CON) hospital lighting followed by 4 days of daytime full spectrum lighting (FS) including violet and blue light wavelengths. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spectral Lighting | Other | Spectral room lighting containing violet and blue wavelengths of light capable of stimulating non-visual opsins including OPN5 and OPN3. |
|
| 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. | 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. |
| 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| temperature | body temperature as measured throughout the day, usually every 3-4 hrs | For the duration of the participant's 4-week study timeline |
| heart rate | heart rate throughout the day, as collected every 3-4 hrs |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James M Greenberg, MD | Children's Hospital Medical Center, Cincinnati | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32879486 | Background | Zhang KX, D'Souza S, Upton BA, Kernodle S, Vemaraju S, Nayak G, Gaitonde KD, Holt AL, Linne CD, Smith AN, Petts NT, Batie M, Mukherjee R, Tiwari D, Buhr ED, Van Gelder RN, Gross C, Sweeney A, Sanchez-Gurmaches J, Seeley RJ, Lang RA. Violet-light suppression of thermogenesis by opsin 5 hypothalamic neurons. Nature. 2020 Sep;585(7825):420-425. doi: 10.1038/s41586-020-2683-0. Epub 2020 Sep 2. | |
| 31968245 |
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| ID | Term |
|---|---|
| D000090124 | Intestinal Failure |
| ID | Term |
|---|---|
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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N-of-1 study design in which each subject will serve as their own control.
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Data analyst will be blinded as to lighting condition exposure of subject (spectral lighting period vs control lighting period) when analyzed samples were collected.
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| For the duration of the participant's 4-week study timeline |
| Phosphorus concentration | concentration of Phosphorus in serum (mg/dL) | Typically collected twice-weekly for the duration of the participant's 4-week study timeline |
| Magnesium concentration | concentration of Magnesium in serum (mg/dL) | Typically collected twice-weekly for the duration of the participant's 4-week study timeline |
| Calcium concentration | concentration of Calcium in serum (mg/dL) | Typically collected twice-weekly for the duration of the participant's 4-week study timeline |
| Sodium concentration | concentration of Sodium in serum (mmol/L) | Typically collected twice-weekly for the duration of the participant's 4-week study timeline |
| Potassium concentration | concentration of Potassium in serum (mmol/L) | Typically collected twice-weekly for the duration of the participant's 4-week study timeline |
| Chloride concentration | concentration of Chloride in serum (mmol/L) | Typically collected twice-weekly for the duration of the participant's 4-week study timeline |
| glucose | glucose concentration in mg/dL | Typically collected twice-weekly for the duration of the participant's 4-week study timeline |
| Blood Urea Nitrogen | blood urea nitrogen concentration in mg/dL | Typically collected twice-weekly for the duration of the participant's 4-week study timeline |
| Creatinine | creatinine concentration in mg/dL | Typically collected twice-weekly for the duration of the participant's 4-week study timeline |
| Albumin | albumin concentration in gm/dL | Typically collected twice-weekly for the duration of the participant's 4-week study timeline |
| Total protein level | total protein concentration in gm/dL | Typically collected twice-weekly for the duration of the participant's 4-week study timeline |
| Alanine Aminotransferase (ALT) | Alanine Aminotransferase concentration in unit/L | Typically collected twice-weekly for the duration of the participant's 4-week study timeline |
| Aspartate Aminotransferase (AST) | Aspartate Aminotransferase (AST) concentration in unit/L | Typically collected twice-weekly for the duration of the participant's 4-week study timeline |
| Alkaline Phosphatase (ALP) | Alkaline Phosphatase (ALP) concentration in unit/L | Typically collected twice-weekly for the duration of the participant's 4-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 4-week study timeline |
| Triglyceride | Triglyceride concentration in mg/dL | Typically collected twice-weekly for the duration of the participant's 4-week study timeline |
| Total Bilirubin | Total Bilirubin concentration in mg/dL | Typically collected twice-weekly for the duration of the participant's 4-week study timeline |
| Direct Bilirubin | Direct Bilirubin concentration in mg/dL | Typically collected twice-weekly for the duration of the participant's 4-week study timeline |
| Background |
| Nayak G, Zhang KX, Vemaraju S, Odaka Y, Buhr ED, Holt-Jones A, Kernodle S, Smith AN, Upton BA, D'Souza S, Zhan JJ, Diaz N, Nguyen MT, Mukherjee R, Gordon SA, Wu G, Schmidt R, Mei X, Petts NT, Batie M, Rao S, Hogenesch JB, Nakamura T, Sweeney A, Seeley RJ, Van Gelder RN, Sanchez-Gurmaches J, Lang RA. Adaptive Thermogenesis in Mice Is Enhanced by Opsin 3-Dependent Adipocyte Light Sensing. Cell Rep. 2020 Jan 21;30(3):672-686.e8. doi: 10.1016/j.celrep.2019.12.043. |
| 14623103 | Background | Tarttelin EE, Bellingham J, Hankins MW, Foster RG, Lucas RJ. Neuropsin (Opn5): a novel opsin identified in mammalian neural tissue. FEBS Lett. 2003 Nov 20;554(3):410-6. doi: 10.1016/s0014-5793(03)01212-2. |
| 36127395 | Background | Hair AB, Good M. Dilemmas in feeding infants with intestinal failure: a neonatologist's perspective. J Perinatol. 2023 Jan;43(1):114-119. doi: 10.1038/s41372-022-01504-4. Epub 2022 Sep 20. |
| 34153281 | Background | Gattini D, Roberts AJ, Wales PW, Beath SV, Evans HM, Hind J, Mercer D, Wong T, Yap J, Belza C, Huysentruyt K, Avitzur Y. Trends in Pediatric Intestinal Failure: A Multicenter, Multinational Study. J Pediatr. 2021 Oct;237:16-23.e4. doi: 10.1016/j.jpeds.2021.06.025. Epub 2021 Jun 18. |