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R2: Restore Resilience in Critically Ill Children

Sponsor
University of Pennsylvania (Other)
Overall Status
Completed
CT.gov ID
NCT04695392
Collaborator
Johns Hopkins University (Other), Children's Hospital of Philadelphia (Other), Boston Children's Hospital (Other)
56
Enrollment
2
Locations
1
Arm
51.8
Actual Duration (Months)
28
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: R2 Bundle
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
56 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Prospective Cohort StudyProspective Cohort Study
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Restore Resilience in Critically Ill Children
Actual Study Start Date :
Sep 5, 2017
Actual Primary Completion Date :
Dec 31, 2021
Actual Study Completion Date :
Dec 31, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention

R2 Bundle

Other: R2 Bundle
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.

Outcome Measures

Primary Outcome Measures

  1. Change in circadian activity ratio (CAR) - Acute Phase [From study enrollment to immediately after endotracheal extubation]

    CAR = Daytime activity/total 24-hr actigraphy activity

Secondary Outcome Measures

  1. Melatonin levels [8 samples over 24 hours on Days 2 and 5 of PICU hospitalization]

    Salivary melatonin levels

  2. Slow-wave EEG activity [First 72 hours of PICU hospitalization]

    Proportion of slow-wave EEG activity during endotracheal intubation

  3. Daily R2 bundle feasibility [From date of enrollment until the date of PICU discharge, assessed for up to 2 months]

    Proportion of the seven R2 elements implemented per day per enrolled subject

  4. Daily R2 bundle adherence [From date of enrollment until the date of PICU discharge, assessed for up to 2 months]

    Proportion of daily feeding and sleep activities that match the subject's preadmission routine

  5. Daily R2 bundle system barriers [From date of enrollment until the date of PICU discharge, assessed for up to 2 months]

    Daily survey of non-patient related factors that prevented R2 bundle implementation

  6. Pain free days [From date of enrollment until the date of PICU discharge, assessed for up to 2 months]

    Proportion of PICU days without pain (Pain score > 3)

  7. Agitation free days [From date of enrollment until the date of PICU discharge, assessed for up to 2 months]

    Proportion of PICU days without agitation (SBS > 0)

  8. Delirium free days [From date of enrollment until the date of PICU discharge, assessed for up to 2 months]

    Proportion of PICU days without delirium (Cornell Assessment for Pediatric Delirium positive)

  9. Iatrogenic withdrawal syndrome free days [From date of enrollment until the date of PICU discharge, assessed for up to 2 months]

    Proportion of PICU days without IWS (WAT-1 > 2)

  10. Peak daily dose of all sedative agents [From date of enrollment until the date of PICU discharge, assessed for up to 2 months]

    Highest daily mg/kg dose of all sedative agents

  11. Cumulative dose of all sedative agents [From date of enrollment until the date of PICU discharge, assessed for up to 2 months]

    Total PICU mg/kg dose of all sedative agents received

  12. Total PICU days of sedation [From date of enrollment until the date of PICU discharge, assessed for up to 2 months]

    Total number of PICU days exposed to sedatives

  13. Time to physiological stability [From date of enrollment until the date of PICU discharge, assessed for up to 2 months]

    Time between the start and stop of vasoactive medications, mechanical ventilation, PICU care

  14. Parent perception of being well-cared-for [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 are better

  15. Change in circadian activity ratio (CAR) - Recovery [From immediately after endotracheal extubation to immediately after PICU discharge]

    CAR = Daytime activity/total 24-hr actigraphy activity

Eligibility Criteria

Criteria

Ages Eligible for Study:
6 Months to 17 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Johns Hopkins University - Charlotte Bloomberg Children's Center Baltimore Maryland United States 21287
2 Children's Hospital of Philadelphia Philadelphia Pennsylvania United States 19104

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Martha AQ Curley, RN, PhD, University of Pennsylvania

Study Documents (Full-Text)

More Information

Publications

Responsible Party:
Martha A.Q. Curley, PhD, RN, Principal Investigator, University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT04695392
Other Study ID Numbers:
  • 828061
First Posted:
Jan 5, 2021
Last Update Posted:
Mar 28, 2022
Last Verified:
Dec 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Respiratory Distress Syndrome
Respiratory Distress Syndrome, Newborn
Acute Lung Injury

Study Results

No Results Posted as of Mar 28, 2022