Clinical trial NCT06094504: Spectral Lighting and Intestinal Failure
Official title: Impact of Full Spectrum Light on Outcomes of Infants With Intestinal Failure
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Intestinal Failure
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2023-10-23
Enrollment: 32
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: N-of-1 study design in which each subject will serve as their own control.
Primary purpose: BASIC_SCIENCE

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.


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.

Primary outcomes:
measure: plasma protein concentration of insulin
timeFrame: 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: plasma protein concentration of leptin
timeFrame: 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:
measure: temperature
timeFrame: For the duration of the participant's 4-week study timeline
measure: heart rate
timeFrame: For the duration of the participant's 4-week study timeline
measure: Phosphorus concentration
timeFrame: Typically collected twice-weekly for the duration of the participant's 4-week study timeline
measure: Magnesium concentration
timeFrame: Typically collected twice-weekly for the duration of the participant's 4-week study timeline
measure: Calcium concentration
timeFrame: Typically collected twice-weekly for the duration of the participant's 4-week study timeline
measure: Sodium concentration
timeFrame: Typically collected twice-weekly for the duration of the participant's 4-week study timeline
measure: Potassium concentration
timeFrame: Typically collected twice-weekly for the duration of the participant's 4-week study timeline
measure: Chloride concentration
timeFrame: Typically collected twice-weekly for the duration of the participant's 4-week study timeline
measure: glucose
timeFrame: Typically collected twice-weekly for the duration of the participant's 4-week study timeline
measure: Blood Urea Nitrogen
timeFrame: Typically collected twice-weekly for the duration of the participant's 4-week study timeline
measure: Creatinine
timeFrame: Typically collected twice-weekly for the duration of the participant's 4-week study timeline
measure: Albumin
timeFrame: Typically collected twice-weekly for the duration of the participant's 4-week study timeline
measure: Total protein level
timeFrame: Typically collected twice-weekly for the duration of the participant's 4-week study timeline
measure: Alanine Aminotransferase (ALT)
timeFrame: Typically collected twice-weekly for the duration of the participant's 4-week study timeline
measure: Aspartate Aminotransferase (AST)
timeFrame: Typically collected twice-weekly for the duration of the participant's 4-week study timeline
measure: Alkaline Phosphatase (ALP)
timeFrame: Typically collected twice-weekly for the duration of the participant's 4-week study timeline
measure: Gamma Glutamyl Transferase (GGT)
timeFrame: Typically collected twice-weekly for the duration of the participant's 4-week study timeline
measure: Triglyceride
timeFrame: Typically collected twice-weekly for the duration of the participant's 4-week study timeline
measure: Total Bilirubin
timeFrame: Typically collected twice-weekly for the duration of the participant's 4-week study timeline
measure: Direct Bilirubin
timeFrame: Typically collected twice-weekly for the duration of the participant's 4-week study timeline
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: James M Greenberg, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.