Spectral Lighting and Intestinal Failure

Официальное название

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

Обзор

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.

Вмешательства

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

Первичные конечные точки

• plasma protein concentration of insulin [Срок оценки: 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.]
• plasma protein concentration of leptin [Срок оценки: 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.]

Вторичные конечные точки (12)

• temperature [Срок оценки: For the duration of the participant's 4-week study timeline]
• heart rate [Срок оценки: For the duration of the participant's 4-week study timeline]
• Phosphorus concentration [Срок оценки: Typically collected twice-weekly for the duration of the participant's 4-week study timeline]
• Magnesium concentration [Срок оценки: Typically collected twice-weekly for the duration of the participant's 4-week study timeline]
• Calcium concentration [Срок оценки: Typically collected twice-weekly for the duration of the participant's 4-week study timeline]
• Sodium concentration [Срок оценки: Typically collected twice-weekly for the duration of the participant's 4-week study timeline]
• Potassium concentration [Срок оценки: Typically collected twice-weekly for the duration of the participant's 4-week study timeline]
• Chloride concentration [Срок оценки: Typically collected twice-weekly for the duration of the participant's 4-week study timeline]
• glucose [Срок оценки: Typically collected twice-weekly for the duration of the participant's 4-week study timeline]
• Blood Urea Nitrogen [Срок оценки: Typically collected twice-weekly for the duration of the participant's 4-week study timeline]
• Creatinine [Срок оценки: Typically collected twice-weekly for the duration of the participant's 4-week study timeline]
• Albumin [Срок оценки: Typically collected twice-weekly for the duration of the participant's 4-week study timeline]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Фундаментальное исследование

Центры проведения

США · 1 центр

• Cincinnati Children's Hospital Medical Center — Cincinnati

Публикации

• 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 34153281

Идентификаторы

NCT: NCT06094504 · 2023-0566

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗