Intestinal FailureNCT06094504

Spectral Lighting and Metabolism

A study testing Spectral Lighting in people with Intestinal Failure, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts

Official record

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Trial summary

Who is it for?: Ages Up to 1 year
Conditions the study is for: Intestinal Failure
What is being tested?: Spectral Lighting
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 32 participants
Where: 1 siteUnited States
Study dates: 1 Mar 2024to 15 Mar 2029
Phase: Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Up to 1 year
All sexes
No healthy volunteers
Child

Who may be able to join

greater than or equal to 32 weeks post-menstrual age (PMA)
have an anticipated CCHMC NICU stay of at least 4 weeks following initiation of study participation

Who cannot join

Infants with aneuploidy (having an abnormal amount of chromosomes) or other lethal congenital anomaly
Infants <32 weeks post-menstrual age (PMA)
Infants actively receiving dialysis, extracorporeal membrane oxygenation (ECMO) or dependent on any ventricular assist device

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site

Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229

Other trials in United States

About this study

Official title: Impact of Broad-Spectrum Light on Markers of Metabolic Regulation in the Neonatal Intensive Care Unit

The goal of this exploratory n-of-1-study is to compare markers of metabolism in infants in a Level IV Neonatal Intensive Care Unit (NICU) between two lighting environments. Investigators are seeking to learn whether supplementing the lighting environment of infants in the NICU 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
Being tested: Spectral Lighting
Medical subject headings: Intestinal Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT06094504
Study group	Role	What they receive
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. Receives: Other: Spectral Lighting

What is being measured

The primary outcome is the main question the study is designed to answer.

urine metabolomics
Urine samples will be collected and compared between lighting conditions for each infant utilizing high-resolution mass spectrometry-based proteomics and metabolomics for comprehensive analysis of networks and pathways influenced by SPEC exposure. We intend to target hormones known to be involved in metabolism and energy management, such as insulin, glucagon, adiponecting and leptin.
Measured: For four weeks, clean urine will be collected with each diaper change, as possible.

Secondary outcomes (20)

temperature
body temperature as measured throughout the day, usually every 3-4 hrs
Measured: For the duration of the participant's 4-week study timeline
heart rate
heart rate throughout the day, as collected every 3-4 hrs
Measured: For the duration of the participant's 4-week study timeline
Phosphorus concentration
concentration of Phosphorus in serum (mg/dL)
Measured: Typically collected twice-weekly for the duration of the participant's 4-week study timeline
Magnesium concentration
concentration of Magnesium in serum (mg/dL)
Measured: Typically collected twice-weekly for the duration of the participant's 4-week study timeline
Calcium concentration
concentration of Calcium in serum (mg/dL)
Measured: Typically collected twice-weekly for the duration of the participant's 4-week study timeline
Sodium concentration
concentration of Sodium in serum (mmol/L)
Measured: Typically collected twice-weekly for the duration of the participant's 4-week study timeline
Potassium concentration
concentration of Potassium in serum (mmol/L)
Measured: Typically collected twice-weekly for the duration of the participant's 4-week study timeline
Chloride concentration
concentration of Chloride in serum (mmol/L)
Measured: Typically collected twice-weekly for the duration of the participant's 4-week study timeline
glucose
glucose concentration in mg/dL
Measured: 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
Measured: Typically collected twice-weekly for the duration of the participant's 4-week study timeline
Creatinine
creatinine concentration in mg/dL
Measured: Typically collected twice-weekly for the duration of the participant's 4-week study timeline
Albumin
albumin concentration in gm/dL
Measured: Typically collected twice-weekly for the duration of the participant's 4-week study timeline
Total protein level
total protein concentration in gm/dL
Measured: Typically collected twice-weekly for the duration of the participant's 4-week study timeline
Alanine Aminotransferase (ALT)
Alanine Aminotransferase concentration in unit/L
Measured: 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
Measured: 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
Measured: 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
Measured: Typically collected twice-weekly for the duration of the participant's 4-week study timeline
Triglyceride
Triglyceride concentration in mg/dL
Measured: Typically collected twice-weekly for the duration of the participant's 4-week study timeline
Total Bilirubin
Total Bilirubin concentration in mg/dL
Measured: Typically collected twice-weekly for the duration of the participant's 4-week study timeline
Direct Bilirubin
Direct Bilirubin concentration in mg/dL
Measured: Typically collected twice-weekly for the duration of the participant's 4-week study timeline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Mar 202415 Mar 2029

First posted23 Oct 2023
Study start1 Mar 2024
Primary completion15 Sep 2028 (estimated)
Study completion15 Mar 2029 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Intestinal FailureStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Single group
Model description: N-of-1 study design in which each subject will serve as their own control.
Masking: None (open label)
Enrolment: 32 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06094504
Sponsor's protocol ID: 2023-0566
Status last verified: Sep 2026
First submitted: 21 Sep 2023
Last updated: 15 Sep 2026
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

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.
PubMed 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. 2020 Jan 21;30(3):672-686.e8. doi: 10.1016/j.celrep.2019.12.043.
PubMed 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.
PubMed 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.
PubMed 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.
PubMed 34153281

Interested in taking part?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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