Spectral Lighting and Intestinal Failure

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Intestinal Failure
• Intervention / Treatment: Other: Spectral Lighting

• Study Type: Interventional
• Enrollment (Estimated): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Cincinnati Children's Hospital Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lighting cycling (Spectral vs Conventional); 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.	Other: Spectral Lighting; Spectral room lighting containing violet and blue wavelengths of light capable of stimulating non-visual opsins including OPN5 and OPN3.

What is the study measuring?

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.	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.

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 4-week study timeline
heart rate	heart rate throughout the day, as collected every 3-4 hrs	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

Collaborators and Investigators

• Sponsor: Children's Hospital Medical Center, Cincinnati
• Investigators: Principal Investigator: James M Greenberg, MD, Children's Hospital Medical Center, Cincinnati

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2024
• Primary Completion (Estimated): September 15, 2026
• Study Completion (Estimated): March 15, 2027

Study Registration Dates

• First Submitted: September 21, 2023
• First Submitted That Met QC Criteria: October 18, 2023
• First Posted (Actual): October 23, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 11, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Failure
• Other Study ID Numbers: 2023-0566

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No