Impact of Broad-Spectrum Light on Markers of Metabolic Regulation in the Neonatal Intensive Care Unit
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- plasma protein concentration of insulin
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
盲法说明
Data analyst will be blinded as to lighting condition exposure of subject (spectral lighting period vs control lighting period) when analyzed samples were collected.
入排标准
- 年龄范围
- — 至 1 Year（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Lighting cycling (Spectral vs Conventional)
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.
干预措施: Spectral Lighting (Other)
结局指标
主要结局
plasma protein concentration of insulin
时间窗: 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.
plasma protein concentration of leptin
时间窗: 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.
urine metabolomics
时间窗: 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.
次要结局
- temperature(For the duration of the participant's 4-week study timeline)
- heart rate(For the duration of the participant's 4-week study timeline)
- Phosphorus concentration(Typically collected twice-weekly for the duration of the participant's 4-week study timeline)
- Magnesium concentration(Typically collected twice-weekly for the duration of the participant's 4-week study timeline)
- Calcium concentration(Typically collected twice-weekly for the duration of the participant's 4-week study timeline)
- Sodium concentration(Typically collected twice-weekly for the duration of the participant's 4-week study timeline)
- Potassium concentration(Typically collected twice-weekly for the duration of the participant's 4-week study timeline)
- Chloride concentration(Typically collected twice-weekly for the duration of the participant's 4-week study timeline)
- glucose(Typically collected twice-weekly for the duration of the participant's 4-week study timeline)
- Blood Urea Nitrogen(Typically collected twice-weekly for the duration of the participant's 4-week study timeline)
- Creatinine(Typically collected twice-weekly for the duration of the participant's 4-week study timeline)
- Albumin(Typically collected twice-weekly for the duration of the participant's 4-week study timeline)
- Total protein level(Typically collected twice-weekly for the duration of the participant's 4-week study timeline)
- Alanine Aminotransferase (ALT)(Typically collected twice-weekly for the duration of the participant's 4-week study timeline)
- Aspartate Aminotransferase (AST)(Typically collected twice-weekly for the duration of the participant's 4-week study timeline)
- Alkaline Phosphatase (ALP)(Typically collected twice-weekly for the duration of the participant's 4-week study timeline)
- Triglyceride(Typically collected twice-weekly for the duration of the participant's 4-week study timeline)
- Gamma Glutamyl Transferase (GGT)(Typically collected twice-weekly for the duration of the participant's 4-week study timeline)
- Total Bilirubin(Typically collected twice-weekly for the duration of the participant's 4-week study timeline)
- Direct Bilirubin(Typically collected twice-weekly for the duration of the participant's 4-week study timeline)