Trial Outcomes & Findings for Restore Resilience in Critically Ill Children (NCT NCT04695392)

NCT ID: NCT04695392

Last Updated: 2024-04-30

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 56 participants
• Primary outcome timeframe: From immediately after endotracheal extubation to PICU discharge, assessed for up to 28 days
• Results posted on: 2024-04-30

Participant Flow

Participant milestones

Measure	Baseline Usual care	Intervention RESTORE Resilience (R2), a 7-item individualized care bundle
Overall Study STARTED	20	36
Overall Study COMPLETED	20	34
Overall Study NOT COMPLETED	0	2

Reasons for withdrawal

Measure	Baseline Usual care	Intervention RESTORE Resilience (R2), a 7-item individualized care bundle
Overall Study Withdrawn by parent/guardian	0	1
Overall Study Withdrawn by physician	0	1

Baseline Characteristics

Restore Resilience in Critically Ill Children

Baseline characteristics by cohort

Measure	Baseline n=20 Participants Usual care	Intervention n=34 Participants RESTORE Resilience (R2), a 7-item individualized care bundle	Total n=54 Participants Total of all reporting groups
Age, Categorical <=18 years	20 Participants n=93 Participants	34 Participants n=4 Participants	54 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Continuous	1.2 years n=93 Participants	5.3 years n=4 Participants	3.6 years n=27 Participants
Sex: Female, Male Female	6 Participants n=93 Participants	14 Participants n=4 Participants	20 Participants n=27 Participants
Sex: Female, Male Male	14 Participants n=93 Participants	20 Participants n=4 Participants	34 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=93 Participants	1 Participants n=4 Participants	3 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	18 Participants n=93 Participants	33 Participants n=4 Participants	51 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	1 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	9 Participants n=93 Participants	13 Participants n=4 Participants	22 Participants n=27 Participants
Race (NIH/OMB) White	8 Participants n=93 Participants	17 Participants n=4 Participants	25 Participants n=27 Participants
Race (NIH/OMB) More than one race	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=93 Participants	3 Participants n=4 Participants	4 Participants n=27 Participants
Region of Enrollment United States	20 participants n=93 Participants	34 participants n=4 Participants	54 participants n=27 Participants

PRIMARY outcome

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

Population: Primary outcome not available for 4 subjects.

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.

Outcome measures

Measure	Baseline n=18 Participants Usual care	Intervention n=32 Participants RESTORE Resilience (R2), a 7-item individualized care bundle
DARE (Daytime Activity Ratio Estimate), Post Extubation	56.7 Percentage of total activity Interval 47.6 to 65.5	61.7 Percentage of total activity Interval 52.7 to 64.8

SECONDARY outcome

Timeframe: Day 5 of PICU hospitalization

Population: Data not available for all subjects.

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

Outcome measures

Measure	Baseline n=9 Participants Usual care	Intervention n=14 Participants RESTORE Resilience (R2), a 7-item individualized care bundle
Delta Between Average Nighttime and Average Daytime Salivary Melatonin Levels	-16.4 pg/mL Interval -28.0 to -0.1	0.1 pg/mL Interval -5.9 to 7.5

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Baseline n=20 Participants Usual care	Intervention n=34 Participants RESTORE Resilience (R2), a 7-item individualized care bundle
Percentage of Study Days Where Light and Sound Were Modulated	0 Percentage of study days Interval 0.0 to 0.0	100 Percentage of study days Interval 75.0 to 100.0

SECONDARY outcome

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

Population: Data unavailable for all study subjects.

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

Outcome measures

Measure	Baseline n=20 Participants Usual care	Intervention n=30 Participants RESTORE Resilience (R2), a 7-item individualized care bundle
Percentage of Study Days Where the Patient Not Fed Enterally After Bedtime	43 Percentage of study days Interval 27.0 to 67.0	57 Percentage of study days Interval 38.0 to 100.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Baseline n=20 Participants Usual care	Intervention n=34 Participants RESTORE Resilience (R2), a 7-item individualized care bundle
Continuity in Nursing Care	67 units on a 0-100 scale Interval 52.0 to 77.0	67 units on a 0-100 scale Interval 57.0 to 80.0

SECONDARY outcome

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

Population: Data not available for all subjects.

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

Outcome measures

Measure	Baseline n=20 Participants Usual care	Intervention n=33 Participants RESTORE Resilience (R2), a 7-item individualized care bundle
Pain Free Days	80 Percentage of study days Interval 67.0 to 95.0	74 Percentage of study days Interval 45.0 to 86.0

SECONDARY outcome

Timeframe: 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)

Outcome measures

Measure	Baseline n=20 Participants Usual care	Intervention n=34 Participants RESTORE Resilience (R2), a 7-item individualized care bundle
Agitation Free Days	55 Percentage of study days Interval 43.0 to 100.0	50 Percentage of study days Interval 25.0 to 75.0

SECONDARY outcome

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

Population: Data not available for all subjects.

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

Outcome measures

Measure	Baseline n=18 Participants Usual care	Intervention n=33 Participants RESTORE Resilience (R2), a 7-item individualized care bundle
Delirium Free Days	74 Percentage of study days Interval 50.0 to 100.0	100 Percentage of study days Interval 60.0 to 100.0

SECONDARY outcome

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

Population: Subjects still in the PICU on day 5 or later.

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

Outcome measures

Measure	Baseline n=15 Participants Usual care	Intervention n=26 Participants RESTORE Resilience (R2), a 7-item individualized care bundle
Iatrogenic Withdrawal Syndrome (IWS) Free Days	100 Percentage of study days Interval 100.0 to 100.0	100 Percentage of study days Interval 75.0 to 100.0

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Baseline n=20 Participants Usual care	Intervention n=34 Participants RESTORE Resilience (R2), a 7-item individualized care bundle
Peak Daily Dose of All Opioid Sedative Agents	3.5 mg/kg/day Interval 1.7 to 6.1	2.9 mg/kg/day Interval 1.0 to 4.2

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Baseline n=20 Participants Usual care	Intervention n=34 Participants RESTORE Resilience (R2), a 7-item individualized care bundle
Cumulative Dose of All Opioid Sedative Agents	12.2 mg/kg Interval 4.6 to 23.5	7.6 mg/kg Interval 2.2 to 18.8

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Baseline n=20 Participants Usual care	Intervention n=34 Participants RESTORE Resilience (R2), a 7-item individualized care bundle
Total PICU Days of Opioid Sedation	6 days Interval 5.0 to 11.0	7 days Interval 4.0 to 11.0

SECONDARY outcome

Timeframe: From date and time of PICU admission until the date and time of PICU discharge

Time between the start and stop of PICU care

Outcome measures

Measure	Baseline n=20 Participants Usual care	Intervention n=34 Participants RESTORE Resilience (R2), a 7-item individualized care bundle
PICU Length of Stay	7.0 days Interval 4.1 to 15.3	7.1 days Interval 4.6 to 11.6

SECONDARY outcome

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

Population: Data not available for all subjects.

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

Outcome measures

Measure	Baseline n=19 Participants Usual care	Intervention n=31 Participants RESTORE Resilience (R2), a 7-item individualized care bundle
Parent Perception of Being well-cared-for	100 Percent Match Interval 100.0 to 100.0	100 Percent Match Interval 86.0 to 100.0

SECONDARY outcome

Timeframe: From study enrollment to endotracheal extubation

Population: Data not available for all subjects.

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.

Outcome measures

Measure	Baseline n=20 Participants Usual care	Intervention n=33 Participants RESTORE Resilience (R2), a 7-item individualized care bundle
DARE (Daytime Activity Ratio Estimate), Acute Phase	53.3 Percentage of total activity Interval 46.6 to 63.4	62.0 Percentage of total activity Interval 55.3 to 65.1

Adverse Events

Baseline

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Intervention

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Baseline n=20 participants at risk Usual care	Intervention n=34 participants at risk RESTORE Resilience (R2), a 7-item individualized care bundle
Respiratory, thoracic and mediastinal disorders Extubation failure (reintubation within 24 hours)	5.0% 1/20 • Number of events 1 • From date of enrollment until the date of PICU discharge, assessed for up to 28 days	2.9% 1/34 • Number of events 1 • From date of enrollment until the date of PICU discharge, assessed for up to 28 days
Respiratory, thoracic and mediastinal disorders Unplanned endotracheal tube extubation	5.0% 1/20 • Number of events 1 • From date of enrollment until the date of PICU discharge, assessed for up to 28 days	0.00% 0/34 • From date of enrollment until the date of PICU discharge, assessed for up to 28 days

Additional Information

Martha A.Q. Curley, RN, PhD

UPENN

Phone: 2155739449

Email: curley@nursing.upenn.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place