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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether special lighting, using blue and violet light, can help infants with intestinal failure better utilize the nutrition they receive. The goal is to determine if this lighting positively affects hormones that control growth and development compared to regular hospital lighting. Infants diagnosed or expected to be diagnosed with intestinal failure and staying in the hospital for at least five weeks might be suitable candidates for this trial. The trial alternates between special lighting and regular lighting every few days to assess any differences in infant growth. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance infant care.

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 prior data suggests that this lighting method is safe for infants with intestinal failure?

Research shows that blue and violet light might help regulate how bodies use food for energy and growth.

Direct information on the safety of this light treatment for people, especially infants with intestinal issues, remains limited. However, its testing in a clinical study suggests it is considered safe enough for human trials. Typically, such studies proceed only after animal tests reveal no major safety issues.

Spectral lighting, being neither a drug nor surgery, might pose fewer risks than other treatments. As a special kind of light, if serious safety concerns existed, the study likely wouldn't continue.

Joining any study involves some unknowns, but researchers closely monitor participants for any side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using spectral lighting for intestinal failure because it introduces a novel approach that harnesses light wavelengths, including violet and blue, to potentially influence biological processes. Unlike traditional treatments that mainly rely on medications or nutritional support, this method leverages environmental modification to possibly enhance patient outcomes. By alternating between conventional and full spectrum lighting, researchers hope to uncover how these light variations can impact recovery and well-being in ways not previously explored.

What evidence suggests that spectral lighting is effective for intestinal failure?

This trial will compare the effects of spectral lighting, including blue and violet light, with conventional hospital lighting. Research has shown that blue and violet light might influence how the body uses energy. Early studies suggested these colors of light can affect hormones involved in growth and development. For infants with intestinal failure, this light might help their bodies use food more effectively. Although this research is ongoing, the main idea is that the right kind of light could improve metabolism in these infants. ^{1 2 3 5 6}

Who Is on the Research Team?

James M Greenberg, MD

Principal Investigator

Children's Hospital Medical Center, Cincinnati

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT06094504

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.

2. withpower.com withpower.com/trial/spectral-lighting-for-intestinal-failure-a57c5

Spectral Lighting for Intestinal Failure · Info for Participants The goal of this exploratory n-of-1-study is to compare markers of metabolism in infants with intestinal failure between two lighting environments.

3. aging.networkofcare.org aging.networkofcare.org/sanmateo/CommunityResources/ClinicalTrials?keyword=%22Intestinal%20Failure%22

San Mateo Clinical Trials The goal of this exploratory n-of-1-study is to compare markers of metabolism in infants with intestinal failure between two lighting environments. ... ~Pre- ...

4. scienceblog.cincinnatichildrens.org scienceblog.cincinnatichildrens.org/spectral-lighting-novel-science-leads-to-innovative-nicu-design/

Spectral Lighting: Novel Science Leads to Innovative NICU ... A new spinoff company called Airway Therapeutics is further developing surfactant technology to further reduce long-term lung problems for ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12383988/

Enhancing Early GI Disease Detection with Spectral ... Early esophagitis management also helps to avoid problems such as Barrett's oesophagus and related cancer. Early therapy can help to reduce ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10371081/

Biologically Aware Lighting for Newborn Intensive Care The spectral lighting system luminaire includes a 6 LED light ... failure such as gastroschisis, intestinal failure/short bowel, and bronchopulmonary dysplasia.