Intestinal Failure
Conditions
Brief summary
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.
Interventions
OTHERSpectral Lighting
Spectral room lighting containing violet and blue wavelengths of light capable of stimulating non-visual opsins including OPN5 and OPN3.
Sponsors
Children's Hospital Medical Center, Cincinnati
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Masking description
Data analyst will be blinded as to lighting condition exposure of subject (spectral lighting period vs control lighting period) when analyzed samples were collected.
Intervention model description
N-of-1 study design in which each subject will serve as their own control.
Eligibility
Sex/Gender
ALL
Age
No minimum to 1 Years
Healthy volunteers
No
Inclusion criteria
* greater than or equal to 32 weeks post-menstrual age (PMA) * have an anticipated CCHMC NICU stay of at least 4 weeks following initiation of study participation
Exclusion criteria
* Infants with aneuploidy (having an abnormal amount of chromosomes) or other lethal congenital anomaly * Infants \<32 weeks post-menstrual age (PMA) * Infants actively receiving dialysis, extracorporeal membrane oxygenation (ECMO) or dependent on any ventricular assist device
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| urine metabolomics | For four weeks, clean urine will be collected with each diaper change, as possible. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| temperature | For the duration of the participant's 4-week study timeline | body temperature as measured throughout the day, usually every 3-4 hrs |
| heart rate | For the duration of the participant's 4-week study timeline | heart rate throughout the day, as collected every 3-4 hrs |
| Phosphorus concentration | Typically collected twice-weekly for the duration of the participant's 4-week study timeline | concentration of Phosphorus in serum (mg/dL) |
| Magnesium concentration | Typically collected twice-weekly for the duration of the participant's 4-week study timeline | concentration of Magnesium in serum (mg/dL) |
| Calcium concentration | Typically collected twice-weekly for the duration of the participant's 4-week study timeline | concentration of Calcium in serum (mg/dL) |
| Sodium concentration | Typically collected twice-weekly for the duration of the participant's 4-week study timeline | concentration of Sodium in serum (mmol/L) |
| Potassium concentration | Typically collected twice-weekly for the duration of the participant's 4-week study timeline | concentration of Potassium in serum (mmol/L) |
| Chloride concentration | Typically collected twice-weekly for the duration of the participant's 4-week study timeline | concentration of Chloride in serum (mmol/L) |
| glucose | Typically collected twice-weekly for the duration of the participant's 4-week study timeline | glucose concentration in mg/dL |
| Blood Urea Nitrogen | Typically collected twice-weekly for the duration of the participant's 4-week study timeline | blood urea nitrogen concentration in mg/dL |
| Creatinine | Typically collected twice-weekly for the duration of the participant's 4-week study timeline | creatinine concentration in mg/dL |
| Albumin | Typically collected twice-weekly for the duration of the participant's 4-week study timeline | albumin concentration in gm/dL |
| Total protein level | Typically collected twice-weekly for the duration of the participant's 4-week study timeline | total protein concentration in gm/dL |
| Alanine Aminotransferase (ALT) | Typically collected twice-weekly for the duration of the participant's 4-week study timeline | Alanine Aminotransferase concentration in unit/L |
| Aspartate Aminotransferase (AST) | Typically collected twice-weekly for the duration of the participant's 4-week study timeline | Aspartate Aminotransferase (AST) concentration in unit/L |
| Alkaline Phosphatase (ALP) | Typically collected twice-weekly for the duration of the participant's 4-week study timeline | Alkaline Phosphatase (ALP) concentration in unit/L |
| Gamma Glutamyl Transferase (GGT) | Typically collected twice-weekly for the duration of the participant's 4-week study timeline | Gamma Glutamyl Transferase (GGT) concentration in unit/L |
| Triglyceride | Typically collected twice-weekly for the duration of the participant's 4-week study timeline | Triglyceride concentration in mg/dL |
| Total Bilirubin | Typically collected twice-weekly for the duration of the participant's 4-week study timeline | Total Bilirubin concentration in mg/dL |
| Direct Bilirubin | Typically collected twice-weekly for the duration of the participant's 4-week study timeline | Direct Bilirubin concentration in mg/dL |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJames M Greenberg, MD
Children's Hospital Medical Center, Cincinnati
Outcome results
None listed