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| Name | Class |
|---|---|
| Johns Hopkins University | OTHER |
| Children's Hospital of Philadelphia | OTHER |
| Boston Children's Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | R2 Bundle |
|
| Baseline | No Intervention | Usual care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| R2 Bundle | Other | During the intervention phase subjects will receive R2.
|
| Measure | Description | Time Frame |
|---|---|---|
| DARE (Daytime Activity Ratio Estimate), Post 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. | From immediately after endotracheal extubation to PICU discharge, assessed for up to 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Delta Between Average Nighttime and Average Daytime Salivary Melatonin Levels | Delta between average nighttime (19:00 to 06:59) and average daytime (07:00 to 18:59) salivary melatonin levels | Day 5 of PICU hospitalization |
| Percentage of Study Days Where Light and Sound Were Modulated |
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Inclusion Criteria:
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:
Administered melatonin within the past week
Has an active do-not-resuscitate plan
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| Name | Affiliation | Role |
|---|---|---|
| Martha AQ Curley, RN, PhD | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins University - Charlotte Bloomberg Children's Center | Baltimore | Maryland | 21287 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34466711 | Background | Perry MA, Dawkins-Henry OS, Awojoodu RE, Blumenthal J, Asaro LA, Wypij D, Kudchadkar SR, Zuppa AF, Curley MAQ. Study protocol for a two-center test of a nurse-implemented chronotherapeutic restoring bundle in critically ill children: RESTORE Resilience (R2). Contemp Clin Trials Commun. 2021 Aug 19;23:100840. doi: 10.1016/j.conctc.2021.100840. eCollection 2021 Sep. | |
| 39133067 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Baseline | Usual care |
| FG001 | Intervention | RESTORE Resilience (R2), a 7-item individualized care bundle |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Baseline | Usual care |
| BG001 | Intervention | RESTORE Resilience (R2), a 7-item individualized care bundle |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | DARE (Daytime Activity Ratio Estimate), Post 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. | Primary outcome not available for 4 subjects. | Posted | Median | Inter-Quartile Range | Percentage of total activity | From immediately after endotracheal extubation to PICU discharge, assessed for up to 28 days |
|
From date of enrollment until the date of PICU discharge, assessed for up to 28 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Baseline | Usual care | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Extubation failure (reintubation within 24 hours) | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Martha A.Q. Curley, RN, PhD | UPENN | 2155739449 | curley@nursing.upenn.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 18, 2020 | Dec 16, 2020 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 29, 2020 | Dec 16, 2020 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D012128 | Respiratory Distress Syndrome |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
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Pre-post study
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|
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 |
| From date of enrollment until the date of PICU discharge, assessed for up to 28 days |
| Percentage of Study Days Where the Patient Not Fed Enterally After Bedtime | Percentage of study days where the patient was not fed enterally after bedtime | From date of enrollment until the date of PICU discharge, assessed for up to 28 days |
| Continuity in Nursing Care | Continuity in Nursing Care Index (CINC) defined as (N nurses/N shifts)*100. Score range 0-100, lower scores are better. | From date of enrollment until the date of PICU discharge, assessed for up to 28 days |
| Pain Free Days | Percentage of PICU days where pain was assessed (0-10 pain scale) without pain (Pain score <4) | From date of PICU admission until the date of PICU discharge, assessed for up to 28 days |
| Agitation Free Days | Percentage of PICU days without agitation (Agitation = State Behavioral Scale [SBS; range -3 to +2] >/= 1) | From date of PICU admission until the date of PICU discharge, assessed for up to 28 days |
| Delirium Free Days | Percentage of PICU days, where delirium was assessed, without delirium (using the CAPD, pCAM-ICU or psCAM-ICU; cut score determined by instrument) | From date of PICU admission until the date of PICU discharge, assessed for up to 28 days |
| Iatrogenic Withdrawal Syndrome (IWS) Free 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) | From date of PICU admission until the date of PICU discharge, assessed for up to 28 days |
| Peak Daily Dose of All Opioid Sedative Agents | Highest daily mg/kg dose of all opioid sedative agents | From date of PICU admission until the date of PICU discharge, assessed for up to 28 days |
| Cumulative Dose of All Opioid Sedative Agents | Total PICU mg/kg dose of all opioid sedative agents received | From date of PICU admission until the date of PICU discharge, assessed for up to 28 days |
| Total PICU Days of Opioid Sedation | Total number of PICU days exposed to opioid sedation | From date of PICU admission until the date of PICU discharge, assessed for up to 28 days |
| PICU Length of Stay | Time between the start and stop of PICU care | From date and time of PICU admission until the date and time of PICU discharge |
| 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 indicate a better match | On the date of PICU discharge, assessed once within an average of 2 weeks post PICU admission |
| DARE (Daytime Activity Ratio Estimate), Acute Phase | 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. | From study enrollment to endotracheal extubation |
| Children's Hospital of Philadelphia |
| Philadelphia |
| Pennsylvania |
| 19104 |
| United States |
| Curley MAQ, Dawkins-Henry OS, Kalvas LB, Perry-Eaddy MA, Georgostathi G, Yuan I, Wypij D, Asaro LA, Zuppa AF, Kudchadkar SR. The Nurse-Implemented Chronotherapeutic Bundle in Critically Ill Children, RESTORE Resilience (R 2 ): Pilot Testing in a Two-Phase Cohort Study, 2017-2021. Pediatr Crit Care Med. 2024 Nov 1;25(11):1051-1064. doi: 10.1097/PCC.0000000000003595. Epub 2024 Aug 12. |
| 41758709 | Derived | Kalvas LB, Dawkins-Henry OS, Ordway MR, Kudchadkar SR, Asaro LA, Wypij D, Curley MAQ. Sleep Health in Critically Ill Children With Acute Respiratory Failure. AACN Adv Crit Care. 2026 Mar 15;37(1):107-121. doi: 10.4037/aacnacc2026606. |
| BG002 |
| Total |
Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Inter-Quartile Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
RESTORE Resilience (R2), a 7-item individualized care bundle |
|
|
| Secondary | Delta Between Average Nighttime and Average Daytime Salivary Melatonin Levels | Delta between average nighttime (19:00 to 06:59) and average daytime (07:00 to 18:59) salivary melatonin levels | Data not available for all subjects. | Posted | Median | Inter-Quartile Range | pg/mL | Day 5 of PICU hospitalization |
|
|
|
| Secondary | Percentage of Study Days Where Light and Sound Were Modulated | 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 | Posted | Median | Inter-Quartile Range | Percentage of study days | From date of enrollment until the date of PICU discharge, assessed for up to 28 days |
|
|
|
| Secondary | Percentage of Study Days Where the Patient Not Fed Enterally After Bedtime | Percentage of study days where the patient was not fed enterally after bedtime | Data unavailable for all study subjects. | Posted | Median | Inter-Quartile Range | Percentage of study days | From date of enrollment until the date of PICU discharge, assessed for up to 28 days |
|
|
|
| Secondary | Continuity in Nursing Care | Continuity in Nursing Care Index (CINC) defined as (N nurses/N shifts)*100. Score range 0-100, lower scores are better. | Posted | Median | Inter-Quartile Range | units on a 0-100 scale | From date of enrollment until the date of PICU discharge, assessed for up to 28 days |
|
|
|
| Secondary | Pain Free Days | Percentage of PICU days where pain was assessed (0-10 pain scale) without pain (Pain score <4) | Data not available for all subjects. | Posted | Median | Inter-Quartile Range | Percentage of study days | From date of PICU admission until the date of PICU discharge, assessed for up to 28 days |
|
|
|
| Secondary | Agitation Free Days | Percentage of PICU days without agitation (Agitation = State Behavioral Scale [SBS; range -3 to +2] >/= 1) | Posted | Median | Inter-Quartile Range | Percentage of study days | From date of PICU admission until the date of PICU discharge, assessed for up to 28 days |
|
|
|
| Secondary | Delirium Free Days | Percentage of PICU days, where delirium was assessed, without delirium (using the CAPD, pCAM-ICU or psCAM-ICU; cut score determined by instrument) | Data not available for all subjects. | Posted | Median | Inter-Quartile Range | Percentage of study days | From date of PICU admission until the date of PICU discharge, assessed for up to 28 days |
|
|
|
| Secondary | Iatrogenic Withdrawal Syndrome (IWS) Free 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) | Subjects still in the PICU on day 5 or later. | Posted | Median | Inter-Quartile Range | Percentage of study days | From date of PICU admission until the date of PICU discharge, assessed for up to 28 days |
|
|
|
| Secondary | Peak Daily Dose of All Opioid Sedative Agents | Highest daily mg/kg dose of all opioid sedative agents | Posted | Median | Inter-Quartile Range | mg/kg/day | From date of PICU admission until the date of PICU discharge, assessed for up to 28 days |
|
|
|
| Secondary | Cumulative Dose of All Opioid Sedative Agents | Total PICU mg/kg dose of all opioid sedative agents received | Posted | Median | Inter-Quartile Range | mg/kg | From date of PICU admission until the date of PICU discharge, assessed for up to 28 days |
|
|
|
| Secondary | Total PICU Days of Opioid Sedation | Total number of PICU days exposed to opioid sedation | Posted | Median | Inter-Quartile Range | days | From date of PICU admission until the date of PICU discharge, assessed for up to 28 days |
|
|
|
| Secondary | PICU Length of Stay | Time between the start and stop of PICU care | Posted | Median | Inter-Quartile Range | days | From date and time of PICU admission until the date and time of PICU discharge |
|
|
|
| Secondary | 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 indicate a better match | Data not available for all subjects. | Posted | Median | Inter-Quartile Range | Percent Match | On the date of PICU discharge, assessed once within an average of 2 weeks post PICU admission |
|
|
|
| Secondary | DARE (Daytime Activity Ratio Estimate), Acute Phase | 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. | Data not available for all subjects. | Posted | Median | Inter-Quartile Range | Percentage of total activity | From study enrollment to endotracheal extubation |
|
|
|
| 20 |
| 0 |
| 20 |
| 1 |
| 20 |
| EG001 | Intervention | RESTORE Resilience (R2), a 7-item individualized care bundle | 0 | 34 | 0 | 34 | 1 | 34 |
| Unplanned endotracheal tube extubation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
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