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Completed

NCT Number: NCT04695392

Restore Resilience in Critically Ill Children

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.

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Key information

Age range

6 month–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins University - Charlotte Bloomberg Children's Center, Baltimore, Maryland, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

R2 Bundle

Other

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.

Primary outcomes

  1. DARE (Daytime Activity Ratio Estimate), Post Extubation

    Time frame: From immediately after endotracheal extubation to PICU discharge, assessed for up to 28 days

    DARE = Daytime Activity Ratio Estimate after endotracheal extubation; DARE was calculated by dividing daytime (07:00-18:59) activity count by 24-hour activity count. A DARE of 50% indicates equal amount of activity between daytime and nighttime periods (loss of circadian rhythm), while a higher DARE indicates increased daytime activity and nighttime sleep consolidation.

Secondary outcomes

  1. Delta Between Average Nighttime and Average Daytime Salivary Melatonin Levels

    Time frame: Day 5 of PICU hospitalization

    Delta between average nighttime (19:00 to 06:59) and average daytime (07:00 to 18:59) salivary melatonin levels

  2. Percentage of Study Days Where Light and Sound Were Modulated

    Time frame: From date of enrollment until the date of PICU discharge, assessed for up to 28 days

    Percentage of study days where light and sound were modulated to reflect day-night variation in light and sound levels; 0 = no study days where light and sound were modulated; 100% = light and sound modulated on all study days

  3. Percentage of Study Days Where the Patient Not Fed Enterally After Bedtime

    Time frame: From date of enrollment until the date of PICU discharge, assessed for up to 28 days

    Percentage of study days where the patient was not fed enterally after bedtime

  4. Continuity in Nursing Care

    Time frame: From date of enrollment until the date of PICU discharge, assessed for up to 28 days

    Continuity in Nursing Care Index (CINC) defined as (N nurses/N shifts)*100. Score range 0-100, lower scores are better.

  5. Pain Free Days

    Time frame: From date of PICU admission until the date of PICU discharge, assessed for up to 28 days

    Percentage of PICU days where pain was assessed (0-10 pain scale) without pain (Pain score <4)

  6. Agitation Free Days

    Time frame: From date of PICU admission until the date of PICU discharge, assessed for up to 28 days

    Percentage of PICU days without agitation (Agitation = State Behavioral Scale [SBS; range -3 to +2] >/= 1)

  7. Delirium Free Days

    Time frame: From date of PICU admission until the date of PICU discharge, assessed for up to 28 days

    Percentage of PICU days, where delirium was assessed, without delirium (using the CAPD, pCAM-ICU or psCAM-ICU; cut score determined by instrument)

  8. Iatrogenic Withdrawal Syndrome (IWS) Free Days

    Time frame: From date of PICU admission until the date of PICU discharge, assessed for up to 28 days

    Percentage of PICU days without IWS (Withdrawal Assessment Tool - version 1 [WAT-1]; range of scores 0-12 where no IWS = WAT-1 < 3)

  9. Peak Daily Dose of All Opioid Sedative Agents

    Time frame: From date of PICU admission until the date of PICU discharge, assessed for up to 28 days

    Highest daily mg/kg dose of all opioid sedative agents

  10. Cumulative Dose of All Opioid Sedative Agents

    Time frame: From date of PICU admission until the date of PICU discharge, assessed for up to 28 days

    Total PICU mg/kg dose of all opioid sedative agents received

  11. Total PICU Days of Opioid Sedation

    Time frame: From date of PICU admission until the date of PICU discharge, assessed for up to 28 days

    Total number of PICU days exposed to opioid sedation

  12. PICU Length of Stay

    Time frame: From date and time of PICU admission until the date and time of PICU discharge

    Time between the start and stop of PICU care

  13. Parent Perception of Being well-cared-for

    Time frame: On the date of PICU discharge, assessed once within an average of 2 weeks post PICU admission

    Percent match on the 7-item family-centered care scale (FCCS); range from 0-100% match; where higher scores indicate a better match

  14. DARE (Daytime Activity Ratio Estimate), Acute Phase

    Time frame: From study enrollment to endotracheal extubation

    DARE = Daytime Activity Ratio Estimate after endotracheal extubation; DARE was calculated by dividing daytime (07:00-18:59) activity count by 24-hour activity count. A DARE of 50% indicates equal amount of activity between daytime and nighttime periods (loss of circadian rhythm), while a higher DARE indicates increased daytime activity and nighttime sleep consolidation.

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • Boston Children's Hospital
  • Children's Hospital of Philadelphia
  • Johns Hopkins University

Registry information

Acronym: R2

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Jan 5, 2021
Registry last updated
May 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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