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Restore Resilience in Critically Ill Children (R2)

Primary Purpose

Acute Respiratory Distress Syndrome

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
R2 Bundle
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Acute Respiratory Distress Syndrome

Eligibility Criteria

6 Months - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Johns Hopkins University - Charlotte Bloomberg Children's Center
  • Children's Hospital of Philadelphia

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention

Arm Description

R2 Bundle

Outcomes

Primary Outcome Measures

Change in circadian activity ratio (CAR) - Acute Phase
CAR = Daytime activity/total 24-hr actigraphy activity

Secondary Outcome Measures

Melatonin levels
Salivary melatonin levels
Slow-wave EEG activity
Proportion of slow-wave EEG activity during endotracheal intubation
Daily R2 bundle feasibility
Proportion of the seven R2 elements implemented per day per enrolled subject
Daily R2 bundle adherence
Proportion of daily feeding and sleep activities that match the subject's preadmission routine
Daily R2 bundle system barriers
Daily survey of non-patient related factors that prevented R2 bundle implementation
Pain free days
Proportion of PICU days without pain (Pain score > 3)
Agitation free days
Proportion of PICU days without agitation (SBS > 0)
Delirium free days
Proportion of PICU days without delirium (Cornell Assessment for Pediatric Delirium positive)
Iatrogenic withdrawal syndrome free days
Proportion of PICU days without IWS (WAT-1 > 2)
Peak daily dose of all sedative agents
Highest daily mg/kg dose of all sedative agents
Cumulative dose of all sedative agents
Total PICU mg/kg dose of all sedative agents received
Total PICU days of sedation
Total number of PICU days exposed to sedatives
Time to physiological stability
Time between the start and stop of vasoactive medications, mechanical ventilation, PICU care
Parent perception of being well-cared-for
Percent match on the 7-item family-centered care scale (FCCS); range from 0-100% match; where higher scores are better
Change in circadian activity ratio (CAR) - Recovery
CAR = Daytime activity/total 24-hr actigraphy activity

Full Information

First Posted
December 22, 2020
Last Updated
March 24, 2022
Sponsor
University of Pennsylvania
Collaborators
Johns Hopkins University, Children's Hospital of Philadelphia, Boston Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04695392
Brief Title
Restore Resilience in Critically Ill Children
Acronym
R2
Official Title
Restore Resilience in Critically Ill Children
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
September 5, 2017 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pennsylvania
Collaborators
Johns Hopkins University, Children's Hospital of Philadelphia, Boston Children's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Distress Syndrome

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Prospective Cohort Study
Masking
None (Open Label)
Allocation
N/A
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
R2 Bundle
Intervention Type
Other
Intervention Name(s)
R2 Bundle
Intervention Description
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 Outcome Measure Information:
Title
Change in circadian activity ratio (CAR) - Acute Phase
Description
CAR = Daytime activity/total 24-hr actigraphy activity
Time Frame
From study enrollment to immediately after endotracheal extubation
Secondary Outcome Measure Information:
Title
Melatonin levels
Description
Salivary melatonin levels
Time Frame
8 samples over 24 hours on Days 2 and 5 of PICU hospitalization
Title
Slow-wave EEG activity
Description
Proportion of slow-wave EEG activity during endotracheal intubation
Time Frame
First 72 hours of PICU hospitalization
Title
Daily R2 bundle feasibility
Description
Proportion of the seven R2 elements implemented per day per enrolled subject
Time Frame
From date of enrollment until the date of PICU discharge, assessed for up to 2 months
Title
Daily R2 bundle adherence
Description
Proportion of daily feeding and sleep activities that match the subject's preadmission routine
Time Frame
From date of enrollment until the date of PICU discharge, assessed for up to 2 months
Title
Daily R2 bundle system barriers
Description
Daily survey of non-patient related factors that prevented R2 bundle implementation
Time Frame
From date of enrollment until the date of PICU discharge, assessed for up to 2 months
Title
Pain free days
Description
Proportion of PICU days without pain (Pain score > 3)
Time Frame
From date of enrollment until the date of PICU discharge, assessed for up to 2 months
Title
Agitation free days
Description
Proportion of PICU days without agitation (SBS > 0)
Time Frame
From date of enrollment until the date of PICU discharge, assessed for up to 2 months
Title
Delirium free days
Description
Proportion of PICU days without delirium (Cornell Assessment for Pediatric Delirium positive)
Time Frame
From date of enrollment until the date of PICU discharge, assessed for up to 2 months
Title
Iatrogenic withdrawal syndrome free days
Description
Proportion of PICU days without IWS (WAT-1 > 2)
Time Frame
From date of enrollment until the date of PICU discharge, assessed for up to 2 months
Title
Peak daily dose of all sedative agents
Description
Highest daily mg/kg dose of all sedative agents
Time Frame
From date of enrollment until the date of PICU discharge, assessed for up to 2 months
Title
Cumulative dose of all sedative agents
Description
Total PICU mg/kg dose of all sedative agents received
Time Frame
From date of enrollment until the date of PICU discharge, assessed for up to 2 months
Title
Total PICU days of sedation
Description
Total number of PICU days exposed to sedatives
Time Frame
From date of enrollment until the date of PICU discharge, assessed for up to 2 months
Title
Time to physiological stability
Description
Time between the start and stop of vasoactive medications, mechanical ventilation, PICU care
Time Frame
From date of enrollment until the date of PICU discharge, assessed for up to 2 months
Title
Parent perception of being well-cared-for
Description
Percent match on the 7-item family-centered care scale (FCCS); range from 0-100% match; where higher scores are better
Time Frame
On the date of PICU discharge, assessed once within an average of 2 weeks post PICU admission
Title
Change in circadian activity ratio (CAR) - Recovery
Description
CAR = Daytime activity/total 24-hr actigraphy activity
Time Frame
From immediately after endotracheal extubation to immediately after PICU discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martha AQ Curley, RN, PhD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins University - Charlotte Bloomberg Children's Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
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Restore Resilience in Critically Ill Children

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