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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

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… Read more about this study

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
Are there results?
Not yet: the study is under way

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.

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 groupRoleWhat they receive
Lighting cycling (Spectral vs Conventional)ExperimentalThe 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.

  1. 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)

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. glucose

    glucose concentration in mg/dL

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

  10. 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

  11. Creatinine

    creatinine concentration in mg/dL

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

  12. Albumin

    albumin concentration in gm/dL

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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

  18. Triglyceride

    Triglyceride concentration in mg/dL

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

  19. Total Bilirubin

    Total Bilirubin concentration in mg/dL

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

  20. 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. First posted23 Oct 2023
  2. Study start1 Mar 2024
  3. Primary completion15 Sep 2028 (estimated)
  4. Study completion15 Mar 2029 (estimated)

Resources

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

Questions about this trial

What is this clinical trial studying?

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

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

urine metabolomics (time frame: For four weeks, clean urine will be collected with each diaper change, as possible.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06094504, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.

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