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Spectral Lighting and Metabolism

StatusEnrolling by Invitation
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 2 years later Sep 15, 2026 → Sep 15, 2028
Primary endpoint removed 2 → 1 primary endpoints
See other at-risk trials from Children's Hospital Medical Center, Cincinnati

Record History

  1. Primary completion pushed from Sep 15, 2026 to Sep 15, 2028 Primary endpoint(s) modified · Lead sponsor: Children's Hospital Medical Center, Cincinnati to Children's Hospital Medical Center, Cincinnati · Completion pushed from Mar 15, 2027 to Mar 15, 2029 · 5 more Show 8 more changesShow less
    • Primary endpoint(s) modified
    • Lead sponsor: Children's Hospital Medical Center, Cincinnati to Children's Hospital Medical Center, Cincinnati
    • Completion pushed from Mar 15, 2027 to Mar 15, 2029
    • Eligibility criteria shortened, about 8 words
    • Secondary endpoints: details revised at 20 of 20 entries
    • Site details revised
    • Publications: details revised at 5 of 5 entries
    • Study title shortened, about 1 word
  2. Secondary endpoints: details revised at 20 of 20 entriesv4
  3. Secondary endpoints: details revised at 19 of 20 entries Eligibility criteria expanded, about 2 wordsv3 Show 1 more changeShow less
    • Eligibility criteria expanded, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  4. Trial status: Not Yet Recruiting to Enrolling by Invitation Start date: Oct 15, 2023 to Mar 1, 2024 · Study sites: 0 to 1 · Primary completion date: Apr 15, 2026 to Sep 15, 2026 · 1 morev2 Show 4 more changesShow less
    • Start date: Oct 15, 2023 to Mar 1, 2024
    • Study sites: 0 to 1
    • Primary completion date: Apr 15, 2026 to Sep 15, 2026
    • Completion date: Oct 15, 2026 to Mar 15, 2027
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06094504
Lead Sponsor Children's Hospital Medical Center, Cincinnati
Conditions Intestinal Failure
Enrollment 32 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov