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Enrolling by Invitation

NCT Number: NCT06094504

Spectral Lighting and Intestinal Failure

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.

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Key information

Conditions

Intestinal Failure Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases

Age range

Up to 1 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Spectral Lighting

Other

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

Primary outcomes

  1. plasma protein concentration of insulin

    Time frame: 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.

    Protein concentrations of plasma insulin as analyzed by SomaScan large scale proteomics assay will be compared among plasma samples taken in lighting conditions and between each lighting condition and dark.

  2. plasma protein concentration of leptin

    Time frame: 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.

    Protein concentrations of plasma insulin as analyzed by SomaScan large scale proteomics assay will be compared among plasma samples taken in lighting conditions and between each lighting condition and dark.

Secondary outcomes

  1. temperature

    Time frame: For the duration of the participant's 4-week study timeline

    body temperature as measured throughout the day, usually every 3-4 hrs

  2. heart rate

    Time frame: For the duration of the participant's 4-week study timeline

    heart rate throughout the day, as collected every 3-4 hrs

  3. Phosphorus concentration

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

    concentration of Phosphorus in serum (mg/dL)

  4. Magnesium concentration

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

    concentration of Magnesium in serum (mg/dL)

  5. Calcium concentration

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

    concentration of Calcium in serum (mg/dL)

  6. Sodium concentration

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

    concentration of Sodium in serum (mmol/L)

  7. Potassium concentration

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

    concentration of Potassium in serum (mmol/L)

  8. Chloride concentration

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

    concentration of Chloride in serum (mmol/L)

  9. glucose

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

    glucose concentration in mg/dL

  10. Blood Urea Nitrogen

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

    blood urea nitrogen concentration in mg/dL

  11. Creatinine

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

    creatinine concentration in mg/dL

  12. Albumin

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

    albumin concentration in gm/dL

  13. Total protein level

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

    total protein concentration in gm/dL

  14. Alanine Aminotransferase (ALT)

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

    Alanine Aminotransferase concentration in unit/L

  15. Aspartate Aminotransferase (AST)

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

    Aspartate Aminotransferase (AST) concentration in unit/L

  16. Alkaline Phosphatase (ALP)

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

    Alkaline Phosphatase (ALP) concentration in unit/L

  17. Gamma Glutamyl Transferase (GGT)

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

    Gamma Glutamyl Transferase (GGT) concentration in unit/L

  18. Triglyceride

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

    Triglyceride concentration in mg/dL

  19. Total Bilirubin

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

    Total Bilirubin concentration in mg/dL

  20. Direct Bilirubin

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

    Direct Bilirubin concentration in mg/dL

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Oct 23, 2023
Registry last updated
Dec 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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