[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06094504":3,"trial-entities:NCT06094504":152,"trial-summary:NCT06094504":155},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":15,"conditions":17,"keywords":19,"study_type":20,"primary_purpose":21,"phases":22,"enrollment_info":24,"interventions":27,"primary_outcomes":33,"secondary_outcomes":40,"sex":103,"minimum_age":15,"maximum_age":104,"healthy_volunteers":105,"eligibility_criteria":106,"std_ages":117,"locations":119,"central_contacts":129,"overall_officials":130,"references":134,"see_also_links":151},"NCT06094504","2023-0566","Spectral Lighting and Intestinal Failure","Impact of Full Spectrum Light on Outcomes of Infants With Intestinal Failure","ENROLLING_BY_INVITATION","2027-03-15","2024-12","2024-12-16","2024-03-01","Children's Hospital Medical Center, Cincinnati","OTHER",null,"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.\n\nPre-clinical studies suggest that violet and blue wavelengths of light are involved in molecular pathways that help regulate metabolic activity.",[18],"Intestinal Failure",[],"INTERVENTIONAL","BASIC_SCIENCE",[23],"NA",{"count":25,"type":26},32,"ESTIMATED",[28],{"type":14,"name":29,"description":30,"armGroupLabels":31},"Spectral Lighting","Spectral room lighting containing violet and blue wavelengths of light capable of stimulating non-visual opsins including OPN5 and OPN3.",[32],"Lighting cycling (Spectral vs Conventional)",[34,38],{"measure":35,"description":36,"timeFrame":37},"plasma protein concentration of insulin","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.","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.",{"measure":39,"description":36,"timeFrame":37},"plasma protein concentration of leptin",[41,45,48,52,55,58,61,64,67,70,73,76,79,82,85,88,91,94,97,100],{"measure":42,"description":43,"timeFrame":44},"temperature","body temperature as measured throughout the day, usually every 3-4 hrs","For the duration of the participant's 4-week study timeline",{"measure":46,"description":47,"timeFrame":44},"heart rate","heart rate throughout the day, as collected every 3-4 hrs",{"measure":49,"description":50,"timeFrame":51},"Phosphorus concentration","concentration of Phosphorus in serum (mg\u002FdL)","Typically collected twice-weekly for the duration of the participant's 4-week study timeline",{"measure":53,"description":54,"timeFrame":51},"Magnesium concentration","concentration of Magnesium in serum (mg\u002FdL)",{"measure":56,"description":57,"timeFrame":51},"Calcium concentration","concentration of Calcium in serum (mg\u002FdL)",{"measure":59,"description":60,"timeFrame":51},"Sodium concentration","concentration of Sodium in serum (mmol\u002FL)",{"measure":62,"description":63,"timeFrame":51},"Potassium concentration","concentration of Potassium in serum (mmol\u002FL)",{"measure":65,"description":66,"timeFrame":51},"Chloride concentration","concentration of Chloride in serum (mmol\u002FL)",{"measure":68,"description":69,"timeFrame":51},"glucose","glucose concentration in mg\u002FdL",{"measure":71,"description":72,"timeFrame":51},"Blood Urea Nitrogen","blood urea nitrogen concentration in mg\u002FdL",{"measure":74,"description":75,"timeFrame":51},"Creatinine","creatinine concentration in mg\u002FdL",{"measure":77,"description":78,"timeFrame":51},"Albumin","albumin concentration in gm\u002FdL",{"measure":80,"description":81,"timeFrame":51},"Total protein level","total protein concentration in gm\u002FdL",{"measure":83,"description":84,"timeFrame":51},"Alanine Aminotransferase (ALT)","Alanine Aminotransferase concentration in unit\u002FL",{"measure":86,"description":87,"timeFrame":51},"Aspartate Aminotransferase (AST)","Aspartate Aminotransferase (AST) concentration in unit\u002FL",{"measure":89,"description":90,"timeFrame":51},"Alkaline Phosphatase (ALP)","Alkaline Phosphatase (ALP) concentration in unit\u002FL",{"measure":92,"description":93,"timeFrame":51},"Gamma Glutamyl Transferase (GGT)","Gamma Glutamyl Transferase (GGT) concentration in unit\u002FL",{"measure":95,"description":96,"timeFrame":51},"Triglyceride","Triglyceride concentration in mg\u002FdL",{"measure":98,"description":99,"timeFrame":51},"Total Bilirubin","Total Bilirubin concentration in mg\u002FdL",{"measure":101,"description":102,"timeFrame":51},"Direct Bilirubin","Direct Bilirubin concentration in mg\u002FdL","ALL","1 Year",false,{"inclusion":107,"exclusion":111,"raw_text":116},[108,109,110],"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",[112,113,114,115],"Infants with major congenital anomalies outside of the gastrointestinal tract","Infants with aneuploidy (having an abnormal amount of chromosomes)","Infants \\\u003C32 weeks post-menstrual age (PMA)","Infants who are anticipated to require a major surgery after enrollment other than anastomosis.","Inclusion Criteria:\n\n* greater than or equal to 32 weeks post-menstrual age (PMA)\n* diagnosis or anticipated diagnosis of intestinal failure by qualified provider\n* have an anticipated hospital stay of at least 5 weeks following initiation of study participation\n\nExclusion Criteria:\n\n* Infants with major congenital anomalies outside of the gastrointestinal tract\n* Infants with aneuploidy (having an abnormal amount of chromosomes)\n* Infants \\\u003C32 weeks post-menstrual age (PMA)\n* Infants who are anticipated to require a major surgery after enrollment other than anastomosis.",[118],"CHILD",[120],{"facility":121,"city":122,"state":123,"zip":124,"country":125,"geoPoint":126},"Cincinnati Children's Hospital Medical Center","Cincinnati","Ohio","45229","United States",{"lat":127,"lon":128},39.12711,-84.51439,[],[131],{"name":132,"affiliation":13,"role":133},"James M Greenberg, MD","PRINCIPAL_INVESTIGATOR",[135,139,142,145,148],{"pmid":136,"type":137,"citation":138},"32879486","BACKGROUND","Zhang KX, D'Souza S, Upton BA, Kernodle S, Vemaraju S, Nayak G, Gaitonde KD, Holt AL, Linne CD, Smith AN, Petts NT, Batie M, Mukherjee R, Tiwari D, Buhr ED, Van Gelder RN, Gross C, Sweeney A, Sanchez-Gurmaches J, Seeley RJ, Lang RA. Violet-light suppression of thermogenesis by opsin 5 hypothalamic neurons. Nature. 2020 Sep;585(7825):420-425. doi: 10.1038\u002Fs41586-020-2683-0. Epub 2020 Sep 2.",{"pmid":140,"type":137,"citation":141},"31968245","Nayak G, Zhang KX, Vemaraju S, Odaka Y, Buhr ED, Holt-Jones A, Kernodle S, Smith AN, Upton BA, D'Souza S, Zhan JJ, Diaz N, Nguyen MT, Mukherjee R, Gordon SA, Wu G, Schmidt R, Mei X, Petts NT, Batie M, Rao S, Hogenesch JB, Nakamura T, Sweeney A, Seeley RJ, Van Gelder RN, Sanchez-Gurmaches J, Lang RA. Adaptive Thermogenesis in Mice Is Enhanced by Opsin 3-Dependent Adipocyte Light Sensing. Cell Rep. 2020 Jan 21;30(3):672-686.e8. doi: 10.1016\u002Fj.celrep.2019.12.043.",{"pmid":143,"type":137,"citation":144},"14623103","Tarttelin EE, Bellingham J, Hankins MW, Foster RG, Lucas RJ. Neuropsin (Opn5): a novel opsin identified in mammalian neural tissue. FEBS Lett. 2003 Nov 20;554(3):410-6. doi: 10.1016\u002Fs0014-5793(03)01212-2.",{"pmid":146,"type":137,"citation":147},"36127395","Hair AB, Good M. Dilemmas in feeding infants with intestinal failure: a neonatologist's perspective. J Perinatol. 2023 Jan;43(1):114-119. doi: 10.1038\u002Fs41372-022-01504-4. Epub 2022 Sep 20.",{"pmid":149,"type":137,"citation":150},"34153281","Gattini D, Roberts AJ, Wales PW, Beath SV, Evans HM, Hind J, Mercer D, Wong T, Yap J, Belza C, Huysentruyt K, Avitzur Y. Trends in Pediatric Intestinal Failure: A Multicenter, Multinational Study. J Pediatr. 2021 Oct;237:16-23.e4. doi: 10.1016\u002Fj.jpeds.2021.06.025. Epub 2021 Jun 18.",[],{"nct_id":4,"conditions":153,"biomarkers":154},[18],[],{"nct_id":4,"found":105,"summary":15,"prompt_version":15}]