Spectral Lighting and Intestinal Failure
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Lighting cycling (Spectral vs Conventional) 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
Spectral room lighting containing violet and blue wavelengths of light capable of stimulating non-visual opsins including OPN5 and OPN3.
|
Outcome Measures
Primary Outcome Measures
- plasma protein concentration of insulin [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.]
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 [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.]
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
- temperature [For the duration of the participant's 9-week study timeline]
body temperature as measured throughout the day, usually every 3-4 hrs
- heart rate [For the duration of the participant's 9-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 9-week study timeline]
concentration of Phosphorus in serum (mg/dL)
- Magnesium concentration [Typically collected twice-weekly for the duration of the participant's 9-week study timeline]
concentration of Magnesium in serum (mg/dL)
- Calcium concentration [Typically collected twice-weekly for the duration of the participant's 9-week study timeline]
concentration of Calcium in serum (mg/dL)
- Sodium concentration [Typically collected twice-weekly for the duration of the participant's 9-week study timeline]
concentration of Sodium in serum (mmol/L)
- Potassium concentration [Typically collected twice-weekly for the duration of the participant's 9-week study timeline]
concentration of Potassium in serum (mmol/L)
- Chloride concentration [Typically collected twice-weekly for the duration of the participant's 9-week study timeline]
concentration of Chloride in serum (mmol/L)
- glucose [Typically collected twice-weekly for the duration of the participant's 9-week study timeline]
glucose concentration in mg/dL
- Blood Urea Nitrogen [Typically collected twice-weekly for the duration of the participant's 9-week study timeline]
blood urea nitrogen concentration in mg/dL
- Creatinine [Typically collected twice-weekly for the duration of the participant's 9-week study timeline]
creatinine concentration in mg/dL
- Albumin [Typically collected twice-weekly for the duration of the participant's 9-week study timeline]
albumin concentration in gm/dL
- Total protein level [Typically collected twice-weekly for the duration of the participant's 9-week study timeline]
total protein concentration in gm/dL
- Alanine Aminotransferase (ALT) [Typically collected twice-weekly for the duration of the participant's 9-week study timeline]
Alanine Aminotransferase concentration in unit/L
- Aspartate Aminotransferase (AST) [Typically collected twice-weekly for the duration of the participant's 9-week study timeline]
Aspartate Aminotransferase (AST) concentration in unit/L
- Alkaline Phosphatase (ALP) [Typically collected twice-weekly for the duration of the participant's 9-week study timeline]
Alkaline Phosphatase (ALP) concentration in unit/L
- Gamma Glutamyl Transferase (GGT) [Typically collected twice-weekly for the duration of the participant's 9-week study timeline]
Gamma Glutamyl Transferase (GGT) concentration in unit/L
- Triglyceride [Typically collected twice-weekly for the duration of the participant's 9-week study timeline]
Triglyceride concentration in mg/dL
- Total Bilirubin [Typically collected twice-weekly for the duration of the participant's 9-week study timeline]
Total Bilirubin concentration in mg/dL
- Direct Bilirubin [Typically collected twice-weekly for the duration of the participant's 9-week study timeline]
Direct Bilirubin concentration in mg/dL
Eligibility Criteria
Criteria
Inclusion Criteria:
-
greater than or equal to 32 weeks gestational age
-
diagnosis or anticipated diagnosis of intestinal failure by qualified provider
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Infants <32 weeks gestation
-
have an anticipated hospital stay of at least 9 weeks following initiation of study participation
Exclusion Criteria:
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Infants with major congenital anomalies outside of the gastrointestinal tract
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Infants with aneuploidy (having an abnormal amount of chromosomes)
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Infants <32 weeks gestation
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Infants who are anticipated to require a major surgery after enrollment.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Children's Hospital Medical Center, Cincinnati
Investigators
- Principal Investigator: James M Greenberg, MD, Children's Hospital Medical Center, Cincinnati
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 2023-0566