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A single center pilot trial investigating the feasibility of using actigraphy and salivary melatonin levels to measure the sleep and circadian rhythm of critically ill children aged 3 to 6 years old. This study will also measure the feasibility of providing daytime light exposure as well as restricting all provided nutrition to during daytime hours.
Several of the identified sleep disruptors in a pediatric intensive care environment may not be modifiable, including restricting feeding to daytime hours and providing normal daytime light exposure. This study aims to measure the feasibility of measuring sleep and circadian patterns in a PICU during routine care and during 2 focused sleep promotion interventions: timed daytime light exposure (DLE) and daytime feeding restriction (DFR). The overall objective of this study is to test the hypothesis that, with multi-disciplinary efforts, providing chronotherapeutic care will be feasible and that reliably measuring sleep patterns and the CR of critically ill children with timed salivary melatonin assays and actigraphy is possible.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 1: standard of care | No Intervention | 10 children will be enrolled in the first phase related to determining if using actigraphy and timed saliva melatonin samples can be a feasible way to measure the sleep and circadian rhythm of critically ill children aged 3 to 6 years old while they receive routine critical care. | |
| Phase 2: Daytime light exposure | Experimental | 10 children will undergo the same sleep monitoring and salivary melatonin sampling as phase 1 while receiving timed exposure to a light box of 10,000 lux within 3 feet of their hospital bed for PICU days #2, 3 and 4. |
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| Phase 3: Daytime restricted feeding | Experimental | 10 children will undergo the same sleep monitoring and salivary melatonin sampling as phase 1 while attempting to limit all nutrition (parental or enteral) to being provided during the normal hours that the child is awake at home on PICU days #2, 3, 4. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Daytime light exposure | Other | Participants will be exposed to a 10,000 lux light source within 3 feet of their face/eyes to promote the natural circadian rhythm for 2-3 hours from 10am to 12/1pm depending on their nap time at home |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of monitoring the sleep and circadian rhythm of critically ill children | The number of days that reliable sleep and CR data are obtained using an actigraph and serial salivary melatonin assays | PICU Day 1 through 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of providing daytime light exposure | Feasibility will be defined by the percentage of days when DLE was implemented and the average hours of DLE provided using a bedside DLE log | PICU Day 2 through 4 |
| Feasibility of restricting nutrition to daytime hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amanda B Hassinger, MD | Contact | 716-323-0158 | albrooks@buffalo.edu | |
| Haiping Qiao, MS | Contact | 716-323-0055 | hqiao@upa.chob.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| John R. Oishei Children's Hospital | Recruiting | Buffalo | New York | 14203 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28288026 | Background | Traube C, Silver G, Gerber LM, Kaur S, Mauer EA, Kerson A, Joyce C, Greenwald BM. Delirium and Mortality in Critically Ill Children: Epidemiology and Outcomes of Pediatric Delirium. Crit Care Med. 2017 May;45(5):891-898. doi: 10.1097/CCM.0000000000002324. | |
| 24813131 | Background | Kamdar BB, Kamdar BB, Needham DM. Bundling sleep promotion with delirium prevention: ready for prime time? Anaesthesia. 2014 Jun;69(6):527-31. doi: 10.1111/anae.12686. No abstract available. |
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Our institution has no current ability to create de-identified data sets available to share at this time, but this could change by study completion.
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| ID | Term |
|---|---|
| D020447 | Parasomnias |
| D016638 | Critical Illness |
| ID | Term |
|---|---|
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
| D020969 | Disease Attributes |
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| ID | Term |
|---|---|
| D010789 | Phototherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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Three phase single center pilot study
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| Daytime restricted feeding | Other | Participant's nutrition, parenteral or enteral, will be restricted to the hours when they are normally awake at home. |
|
. The feasibility of daytime restricted feeding will be determined by the percentage of enteral or parenteral nutrition that was provided on each study day outside of the child's daytime feeding period determined by the Intake and Output records in the EMR |
| PICU Day 2 through 4 |
| 23702219 | Background | Kudchadkar SR, Aljohani OA, Punjabi NM. Sleep of critically ill children in the pediatric intensive care unit: a systematic review. Sleep Med Rev. 2014 Apr;18(2):103-10. doi: 10.1016/j.smrv.2013.02.002. Epub 2013 May 21. |
| 30339549 | Background | Pun BT, Balas MC, Barnes-Daly MA, Thompson JL, Aldrich JM, Barr J, Byrum D, Carson SS, Devlin JW, Engel HJ, Esbrook CL, Hargett KD, Harmon L, Hielsberg C, Jackson JC, Kelly TL, Kumar V, Millner L, Morse A, Perme CS, Posa PJ, Puntillo KA, Schweickert WD, Stollings JL, Tan A, D'Agostino McGowan L, Ely EW. Caring for Critically Ill Patients with the ABCDEF Bundle: Results of the ICU Liberation Collaborative in Over 15,000 Adults. Crit Care Med. 2019 Jan;47(1):3-14. doi: 10.1097/CCM.0000000000003482. |
| 33895129 | Background | Berger J, Zaidi M, Halferty I, Kudchadkar SR. Sleep in the Hospitalized Child: A Contemporary Review. Chest. 2021 Sep;160(3):1064-1074. doi: 10.1016/j.chest.2021.04.024. Epub 2021 Apr 22. |
| 38456806 | Background | Hassinger AB, Mody K, Gomez R, Wrotniak BH, Falkowski K, Breuer R, Mennie C, Flagg LK. Validation of the Survey of Sleep Quality in the Pediatric Intensive Care Unit (SSqPICU). J Clin Sleep Med. 2024 Aug 1;20(8):1251-1258. doi: 10.5664/jcsm.11116. |
| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |