Spectral Lighting and Intestinal Failure

Intestinal Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06094504
• Other study ID #: 2023-0566
• Status: Enrolling by invitation
• Phase: N/A
• Start date: March 1, 2024
• Est. completion date: March 15, 2027

Study information

• Verified date: September 2023
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 32
• Est. completion date: March 15, 2027
• Est. primary completion date: September 15, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 1 Year

Eligibility

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.

Related Conditions & MeSH terms

• Intestinal Failure

Intervention

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

Locations

Country	Name	City	State
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	From one week into enrollment through week 5, 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.
Primary	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.	From one week into enrollment through week 5, 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	temperature	body temperature as measured throughout the day, usually every 3-4 hrs	For the duration of the participant's 5-week study timeline
Secondary	heart rate	heart rate throughout the day, as collected every 3-4 hrs	For the duration of the participant's 5-week study timeline
Secondary	Phosphorus concentration	concentration of Phosphorus in serum (mg/dL)	Typically collected twice-weekly for the duration of the participant's 5-week study timeline
Secondary	Magnesium concentration	concentration of Magnesium in serum (mg/dL)	Typically collected twice-weekly for the duration of the participant's 5-week study timeline
Secondary	Calcium concentration	concentration of Calcium in serum (mg/dL)	Typically collected twice-weekly for the duration of the participant's 5-week study timeline
Secondary	Sodium concentration	concentration of Sodium in serum (mmol/L)	Typically collected twice-weekly for the duration of the participant's 9-week study timeline
Secondary	Potassium concentration	concentration of Potassium in serum (mmol/L)	Typically collected twice-weekly for the duration of the participant's 5-week study timeline
Secondary	Chloride concentration	concentration of Chloride in serum (mmol/L)	Typically collected twice-weekly for the duration of the participant's 5-week study timeline
Secondary	glucose	glucose concentration in mg/dL	Typically collected twice-weekly for the duration of the participant's 5-week study timeline
Secondary	Blood Urea Nitrogen	blood urea nitrogen concentration in mg/dL	Typically collected twice-weekly for the duration of the participant's 5-week study timeline
Secondary	Creatinine	creatinine concentration in mg/dL	Typically collected twice-weekly for the duration of the participant's 5-week study timeline
Secondary	Albumin	albumin concentration in gm/dL	Typically collected twice-weekly for the duration of the participant's 5-week study timeline
Secondary	Total protein level	total protein concentration in gm/dL	Typically collected twice-weekly for the duration of the participant's 5-week study timeline
Secondary	Alanine Aminotransferase (ALT)	Alanine Aminotransferase concentration in unit/L	Typically collected twice-weekly for the duration of the participant's 5-week study timeline
Secondary	Aspartate Aminotransferase (AST)	Aspartate Aminotransferase (AST) concentration in unit/L	Typically collected twice-weekly for the duration of the participant's 5-week study timeline
Secondary	Alkaline Phosphatase (ALP)	Alkaline Phosphatase (ALP) concentration in unit/L	Typically collected twice-weekly for the duration of the participant's 5-week study timeline
Secondary	Gamma Glutamyl Transferase (GGT)	Gamma Glutamyl Transferase (GGT) concentration in unit/L	Typically collected twice-weekly for the duration of the participant's 5-week study timeline
Secondary	Triglyceride	Triglyceride concentration in mg/dL	Typically collected twice-weekly for the duration of the participant's 5-week study timeline
Secondary	Total Bilirubin	Total Bilirubin concentration in mg/dL	Typically collected twice-weekly for the duration of the participant's 5-week study timeline
Secondary	Direct Bilirubin	Direct Bilirubin concentration in mg/dL	Typically collected twice-weekly for the duration of the participant's 5-week study timeline