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Spectral Lighting and Intestinal Failure

NCT ID: NCT06094504

Last Updated: 2024-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-01

Study Completion Date

2027-03-15

Brief Summary

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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.

Detailed Description

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Conditions

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Intestinal Failure

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

N-of-1 study design in which each subject will serve as their own control.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Data analyst will be blinded as to lighting condition exposure of subject (spectral lighting period vs control lighting period) when analyzed samples were collected.

Study Groups

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Lighting cycling (Spectral vs Conventional)

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.

Group Type EXPERIMENTAL

Spectral Lighting

Intervention Type OTHER

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

Interventions

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Spectral Lighting

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

Intervention Type OTHER

Eligibility Criteria

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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.
Maximum Eligible Age

1 Year

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Children's Hospital Medical Center, Cincinnati

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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James M Greenberg, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Medical Center, Cincinnati

Locations

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Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 32879486 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31968245 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14623103 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36127395 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34153281 (View on PubMed)

Other Identifiers

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2023-0566

Identifier Type: -

Identifier Source: org_study_id