Spectral Lighting and Intestinal Failure

Official title

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

Overview

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.

Interventions

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

Primary outcome measures

• plasma protein concentration of insulin [Time frame: 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 [Time frame: 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 (12)

• temperature [Time frame: For the duration of the participant's 4-week study timeline]
• heart rate [Time frame: For the duration of the participant's 4-week study timeline]
• Phosphorus concentration [Time frame: Typically collected twice-weekly for the duration of the participant's 4-week study timeline]
• Magnesium concentration [Time frame: Typically collected twice-weekly for the duration of the participant's 4-week study timeline]
• Calcium concentration [Time frame: Typically collected twice-weekly for the duration of the participant's 4-week study timeline]
• Sodium concentration [Time frame: Typically collected twice-weekly for the duration of the participant's 4-week study timeline]
• Potassium concentration [Time frame: Typically collected twice-weekly for the duration of the participant's 4-week study timeline]
• Chloride concentration [Time frame: Typically collected twice-weekly for the duration of the participant's 4-week study timeline]
• glucose [Time frame: Typically collected twice-weekly for the duration of the participant's 4-week study timeline]
• Blood Urea Nitrogen [Time frame: Typically collected twice-weekly for the duration of the participant's 4-week study timeline]
• Creatinine [Time frame: Typically collected twice-weekly for the duration of the participant's 4-week study timeline]
• Albumin [Time frame: Typically collected twice-weekly for the duration of the participant's 4-week study timeline]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Basic science

Study locations

United States · 1 center

• Cincinnati Children's Hospital Medical Center — Cincinnati

Publications

• 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
• 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. PMID 31968245
• 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
• 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
• 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

Identifiers

NCT: NCT06094504 · 2023-0566

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗