Restore Resilience in Critically Ill Children
Condition: Acute Respiratory Distress Syndrome
MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury
Study type: Interventional

Summary: 
      The study design will allow investigators to describe usual care in each PICU and identify
      the facilitating and restraining factors impacting the implementation of R2 at each PICU. The
      purpose of this pilot study is to improve the care, environment, daily routine and sleep
      patterns of children in the PICU. The goal of this study is to learn what can be improved to
      support a critically ill child's healing and circadian rhythms.
    

Detailed description: 
      Hospitals should do the sick no harm. That noted, modern day pediatric intensive care units
      (PICUs) are not healing milieus. Immediately upon admission to the PICU, the child's daily
      routine and sleep patterns are replaced by a well-intended but not patient-centered PICU
      routine. The interprofessional investigative team believes that PICU care and environments
      can be modulated to sustain a young child's circadian rhythm (CR) and support their
      physiological resilience and capacity to heal. The first step in this program of research is
      to pilot-test RESTORE resilience (R2), a 7-item individualized bundle that we hypothesize
      will restore CR in critically ill children using a pre-posttest design. Two separate PICUs
      will each enroll 10 baseline subjects followed by 20 intervention subjects, 6 months to 18
      years of age, who are intubated and mechanically ventilated for acute respiratory failure.
      Specifically, as soon as possible after PICU admission, parents will be interviewed to create
      an individualized chronotherapeutic bundle to include (1) focused effort to replicate the
      child's pre-hospitalization daily routine (bedtime/wake time, bedtime/arousal routine, nap
      time, feeding schedule, active periods), (2) cycled day-night lighting and modulation of
      sound to match the child's routine, (3) minimal yet effective sedation using a
      nurse-implemented goal-directed sedation plan (RESTORE), (4) night fasting with bolus enteral
      daytime feedings, (5) early, developmentally-appropriate, progressive exercise and mobility
      (PICU Up!), (6) continuity in nursing care, and (7) parent diaries. The overall objective of
      this study is to pilot-test an intervention that can be implemented in any PICU that will
      improve sleep-wake patterns with restoration/maintenance of circadian rhythms in critically
      ill children with acute respiratory failure. Results of this pilot study will be used to
      inform the design of an adequately powered multicenter randomized trial of R2.
    

Intervention name(s): R2 Bundle
Intervention type(s): Other
Intervention description(s): During the intervention phase subjects will receive R2.
Focused effort to replicate the child's pre-hospitalization daily routine (bedtime/wake time, bedtime/arousal routine, nap time, feeding schedule, active periods),
Cycled day-night lighting and modulation of sound to match the child's routine,
Minimal yet effective sedation using a nurse-implemented goal-directed sedation plan (RESTORE),
Night fasting with bolus enteral daytime feedings,
Early, developmentally-appropriate, progressive exercise and mobility (PICU Up!),
Continuity in nursing care, and
Parent diaries.
Intervention model: Single Group Assignment
Intervention model description: Prospective Cohort Study
Masking: None (Open Label)
Primary purpose: Supportive Care