Spectral Lighting for Intestinal Failure

Overseen By Katherine Gruner, M.S.

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Children's Hospital Medical Center, Cincinnati

Disqualifiers: Major congenital anomalies, Aneuploidy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

32 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop my current medications for this trial?

The trial information does not specify whether participants need to stop taking their current medications. It is best to discuss this with the trial coordinators or your healthcare provider.

What data supports the effectiveness of the treatment Spectral Lighting for Intestinal Failure?

Research on lighting systems in neonatal intensive care units suggests that specific lighting conditions, like cycled light, can positively impact health. While this is not directly related to intestinal failure, it indicates that lighting can influence physiological processes, which might be relevant for Spectral Lighting's potential benefits. ^{1 2 3 4 5}

How is the treatment Spectral Lighting unique for intestinal failure?

Spectral Lighting is unique because it uses specific wavelengths of light to potentially enhance intestinal perfusion (blood flow) and oxygenation, which is different from traditional treatments that do not utilize light-based methods. This approach may offer a novel way to monitor and improve intestinal function by targeting the mucosal surface with visible light. ^{6 7 8 9 10}

Research Team

James M Greenberg, MD

Principal Investigator

Children's Hospital Medical Center, Cincinnati

Eligibility Criteria

This trial is for infants diagnosed with or expected to have intestinal failure, who are at least 32 weeks gestational age and will likely stay in the hospital for over 9 weeks after joining the study.

Inclusion Criteria

I am at least 32 weeks pregnant.

I have been diagnosed with or am expected to be diagnosed with intestinal failure.

My infant is expected to stay in the hospital for at least 9 weeks after joining the study.

Exclusion Criteria

My infant has major birth defects not related to the digestive system.

My infant has a genetic chromosome abnormality.

My baby was born before 32 weeks of pregnancy.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants are exposed to alternating lighting environments to assess metabolic markers

4 weeks

Daily monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Spectral Lighting

Trial Overview The study tests if special lighting (spectral lighting) that includes blue and violet light waves can help babies with intestinal failure use their nutrition better by affecting growth-related hormones, compared to normal lights.

Participant Groups

Group I: Lighting cycling (Spectral vs Conventional) Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Children's Hospital Medical Center, Cincinnati

Lead Sponsor

Trials

844

Recruited

6,566,000+

Findings from Research

Cycled light in an intensive care unit may improve health outcomes for preterm infants compared to dim or non-cycled light, suggesting its potential therapeutic benefits.

Patients in a specially designed lighting environment reported a more positive experience compared to those in a standard room, indicating that lighting interventions can enhance the overall atmosphere in intensive care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Let there be light and darkness: findings from a prestudy concerning cycled light in the intensive care unit environment. Engwall, M., Fridh, I., Bergbom, I., et al.[2018]

References

1. United States pubmed.ncbi.nlm.nih.gov

Biologically Aware Lighting for Newborn Intensive Care. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Biologically aware lighting for newborn intensive care. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Let there be light and darkness: findings from a prestudy concerning cycled light in the intensive care unit environment. [2018]

4. England pubmed.ncbi.nlm.nih.gov

An evaluation of the characteristics and performance of neonatal phototherapy equipment. [2019]

5. Australia pubmed.ncbi.nlm.nih.gov

Overhead is superior to underneath light-emitting diode phototherapy in the treatment of neonatal jaundice: a comparative study. [2013]

6. United States pubmed.ncbi.nlm.nih.gov

Mucosal exposure to light during routine endoscopy. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Intestinal perfusion monitoring using photoplethysmography. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Design and implementation of a wireless capsule suitable for autofluorescence intensity detection in biological tissues. [2012]

9. United States pubmed.ncbi.nlm.nih.gov

Endoscopic reflectance spectrophotometry and visible light spectroscopy in clinical gastrointestinal studies. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Relationship Between Near-Infrared Spectroscopy and Transabdominal Ultrasonography: Noninvasive Monitoring of Intestinal Function in Neonates. [2019]