An interventional study of Spectral Lighting in Intestinal Failure, sponsored by Children's Hospital Medical Center, Cincinnati. Enrolling by invitation at 1 site in United States. Open to participants aged Up to 1 Year. Per ClinicalTrials.gov, last updated 2026-09-15.
Sponsored by Children's Hospital Medical Center, Cincinnati · Not applicable, Interventional, and Basic science
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.
64 studies on the registry are indexed under Intestinal Failure; 17 are open to participants now.
This study's planned enrollment of 32 is below the median of 38 across 42 interventional studies indexed under Intestinal Failure.
Browse Intestinal Failure studies →Children's Hospital Medical Center, Cincinnati is the lead sponsor of 673 studies on the registry; 130 are open to participants now.
Of its 57 completed or terminated interventional studies of FDA-regulated products, 31 (54%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Other: Spectral Lighting
Spectral room lighting containing violet and blue wavelengths of light capable of stimulating non-visual opsins including OPN5 and OPN3.
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.
Time frame: For four weeks, clean urine will be collected with each diaper change, as possible.
temperature
body temperature as measured throughout the day, usually every 3-4 hrs
Time frame: For the duration of the participant's 4-week study timeline
heart rate
heart rate throughout the day, as collected every 3-4 hrs
Time frame: For the duration of the participant's 4-week study timeline
Phosphorus concentration
concentration of Phosphorus in serum (mg/dL)
Time frame: Typically collected twice-weekly for the duration of the participant's 4-week study timeline
Magnesium concentration
concentration of Magnesium in serum (mg/dL)
Time frame: Typically collected twice-weekly for the duration of the participant's 4-week study timeline
Calcium concentration
concentration of Calcium in serum (mg/dL)
Time frame: Typically collected twice-weekly for the duration of the participant's 4-week study timeline
Sodium concentration
concentration of Sodium in serum (mmol/L)
Time frame: Typically collected twice-weekly for the duration of the participant's 4-week study timeline
Potassium concentration
concentration of Potassium in serum (mmol/L)
Time frame: Typically collected twice-weekly for the duration of the participant's 4-week study timeline
Chloride concentration
concentration of Chloride in serum (mmol/L)
Time frame: Typically collected twice-weekly for the duration of the participant's 4-week study timeline
glucose
glucose concentration in mg/dL
Time frame: 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
Time frame: Typically collected twice-weekly for the duration of the participant's 4-week study timeline
Creatinine
creatinine concentration in mg/dL
Time frame: Typically collected twice-weekly for the duration of the participant's 4-week study timeline
Albumin
albumin concentration in gm/dL
Time frame: Typically collected twice-weekly for the duration of the participant's 4-week study timeline
Total protein level
total protein concentration in gm/dL
Time frame: Typically collected twice-weekly for the duration of the participant's 4-week study timeline
Alanine Aminotransferase (ALT)
Alanine Aminotransferase concentration in unit/L
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Typically collected twice-weekly for the duration of the participant's 4-week study timeline
Triglyceride
Triglyceride concentration in mg/dL
Time frame: Typically collected twice-weekly for the duration of the participant's 4-week study timeline
Total Bilirubin
Total Bilirubin concentration in mg/dL
Time frame: Typically collected twice-weekly for the duration of the participant's 4-week study timeline
Direct Bilirubin
Direct Bilirubin concentration in mg/dL
Time frame: Typically collected twice-weekly for the duration of the participant's 4-week study timeline
Started Mar 2024 (actual). Primary completion is estimated for Sep 2028, 54 months after the start.
Of 17 interventional studies with no phase under Intestinal Failure, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 59. This study's planned 54 months is above that.
How these figures are worked out, and which studies are left out of them.
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Children's Hospital Medical Center, Cincinnati →