Spectral Lighting and Intestinal Failure

NCT06094504 | Enrolling By Invitation

• 1 other identifier: 2023-0566
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Intestinal Failure

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (20)

• temperature

  For the duration of the participant's 4-week study timeline

• heart rate

  For the duration of the participant's 4-week study timeline

• Phosphorus concentration

  Typically collected twice-weekly for the duration of the participant's 4-week study timeline

• Magnesium concentration

  Typically collected twice-weekly for the duration of the participant's 4-week study timeline

• Calcium concentration

  Typically collected twice-weekly for the duration of the participant's 4-week study timeline

Study Arms (1)

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.

Other: Spectral Lighting

Interventions

Spectral Lighting OTHER

Spectral room lighting containing violet and blue wavelengths of light capable of stimulating non-visual opsins including OPN5 and OPN3.

Lighting cycling (Spectral vs Conventional)

Eligibility Criteria

• Age: Up to 1 Year
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Related Publications (5)

• 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.

  PMID: 32879486 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.

  PMID: 31968245 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.

  PMID: 14623103 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.

  PMID: 36127395 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.

  PMID: 34153281 BACKGROUND

MeSH Terms

Conditions

Intestinal Failure

Condition Hierarchy (Ancestors)

Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• James M Greenberg, MD

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Data analyst will be blinded as to lighting condition exposure of subject (spectral lighting period vs control lighting period) when analyzed samples were collected.
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: N-of-1 study design in which each subject will serve as their own control.

Study Record Dates

• First Submitted: September 21, 2023
• First Posted: October 23, 2023
• Study Start: March 1, 2024
• Primary Completion (Estimated): September 15, 2026
• Study Completion (Estimated): March 15, 2027
• Last Updated: December 16, 2024

Record last verified: 2024-12

Locations

US (1)