Clinical trial NCT04695392: Restore Resilience in Critically Ill Children
Official title: Restore Resilience in Critically Ill Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Respiratory Distress Syndrome
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Johns Hopkins University
name: Children's Hospital of Philadelphia
name: Boston Children's Hospital
First posted: 2021-01-05
Enrollment: 56
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pre-post study
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: Inclusion Criteria:

* PICU admission at one of the study sites in which elements of R2 are typically but sporadically implemented
* Transferred to the PICU from another hospital unit/ward with ≤4 nights in the hospital (≤2 nights in PICU)
* Between the ages 6 months and 18 years at the time of enrollment (has not had their 18th birthday)
* Intubated and mechanically ventilated for acute airway or parenchymal disease within last 48 hours
* Expected to be intubated for more than 12 hours past enrollment
* Parent/Guardian providing consent, provides primary care for subject

Exclusion Criteria:

* A baseline cognitive dysfunction, measured by the Pediatric Cerebral Performance Category (PCPC ≥4)
* A history of an uncontrolled seizure disorder (seizure within past 3 months), cerebral hypertension, neuromuscular respiratory failure, ventilator dependence (excluding BiPAP or CPAP at night)
* A history of inability to tolerate bolus enteral feeds (full J-Tube fed patients)
* The presence of any of the following within 24 hours of admission:

  * Modal pain scores greater than 4
  * Persistent hypotension/hypertension unresponsive to standard therapies
  * Use of High Frequency Oscillatory Ventilation or Extracorporeal Membrane Oxygenation
* Administered melatonin within the past week
* Has an active do-not-resuscitate plan

Primary outcomes:
measure: DARE (Daytime Activity Ratio Estimate), Post Extubation
timeFrame: From immediately after endotracheal extubation to PICU discharge, assessed for up to 28 days
Secondary outcomes:
measure: Delta Between Average Nighttime and Average Daytime Salivary Melatonin Levels
timeFrame: Day 5 of PICU hospitalization
measure: Percentage of Study Days Where Light and Sound Were Modulated
timeFrame: From date of enrollment until the date of PICU discharge, assessed for up to 28 days
measure: Percentage of Study Days Where the Patient Not Fed Enterally After Bedtime
timeFrame: From date of enrollment until the date of PICU discharge, assessed for up to 28 days
measure: Continuity in Nursing Care
timeFrame: From date of enrollment until the date of PICU discharge, assessed for up to 28 days
measure: Pain Free Days
timeFrame: From date of PICU admission until the date of PICU discharge, assessed for up to 28 days
measure: Agitation Free Days
timeFrame: From date of PICU admission until the date of PICU discharge, assessed for up to 28 days
measure: Delirium Free Days
timeFrame: From date of PICU admission until the date of PICU discharge, assessed for up to 28 days
measure: Iatrogenic Withdrawal Syndrome (IWS) Free Days
timeFrame: From date of PICU admission until the date of PICU discharge, assessed for up to 28 days
measure: Peak Daily Dose of All Opioid Sedative Agents
timeFrame: From date of PICU admission until the date of PICU discharge, assessed for up to 28 days
measure: Cumulative Dose of All Opioid Sedative Agents
timeFrame: From date of PICU admission until the date of PICU discharge, assessed for up to 28 days
measure: Total PICU Days of Opioid Sedation
timeFrame: From date of PICU admission until the date of PICU discharge, assessed for up to 28 days
measure: PICU Length of Stay
timeFrame: From date and time of PICU admission until the date and time of PICU discharge
measure: Parent Perception of Being well-cared-for
timeFrame: On the date of PICU discharge, assessed once within an average of 2 weeks post PICU admission
measure: DARE (Daytime Activity Ratio Estimate), Acute Phase
timeFrame: From study enrollment to endotracheal extubation
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University - Charlotte Bloomberg Children's Center
state: Maryland
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Martha AQ Curley, RN, PhD
role: PRINCIPAL_INVESTIGATOR
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