Spectral Lighting and Intestinal Failure

Cincinnati Children's Hospital Medical Center

Status: Invitation-only

Conditions: Intestinal Failure

Treatments: Other: Spectral Lighting

Study type: Interventional

Funder types: Other

Identifiers

NCT06094504

2023-0566

Details and patient eligibility

About

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.

Enrollment: 32 estimated patients

Sex: All

Ages: Under 1 year old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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32 participants in 1 patient group

Lighting cycling (Spectral vs Conventional)

Experimental group

Description:

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.

Treatment:

Other: Spectral Lighting