Children, Only, Circadian Dysrhythmia, Critical Illness, Sleep Disturbance
Conditions
Keywords
Sleep disruption, circadian rhythm, critical care, pediatrics
Brief summary
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.
Detailed description
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.
Interventions
OTHERDaytime light exposure
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
OTHERDaytime restricted feeding
Participant's nutrition, parenteral or enteral, will be restricted to the hours when they are normally awake at home.
Sponsors
State University of New York at Buffalo
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Three phase single center pilot study
Eligibility
Sex/Gender
ALL
Age
3 Years to 6 Years
Healthy volunteers
No
Inclusion criteria
1. Child age 3 to 6 years old on the day of PICU admission 2. English-speaking parent at the bedside 3. Child expected to remain in the PICU over 24 to 48 hours
Exclusion criteria
1. Child is in end-of-life care 2. The child is receiving neuromuscular blockade for any reason 3. Caregiver or parent not at the bedside
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of monitoring the sleep and circadian rhythm of critically ill children | PICU Day 1 through 4 | The number of days that reliable sleep and CR data are obtained using an actigraph and serial salivary melatonin assays |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of providing daytime light exposure | PICU Day 2 through 4 | 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 |
| Feasibility of restricting nutrition to daytime hours | PICU Day 2 through 4 | . 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 |
Countries
United States
Contacts
CONTACTAmanda B Hassinger, MD
CONTACTHaiping Qiao, MS
Outcome results
None listed