Adults 6 Months to 17, any sex, with Acute Respiratory Distress Syndrome. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
DARE (Daytime Activity Ratio Estimate), Post ExtubationPrimary· 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.
Group
Value
95% CI
Baseline
56.7
47.6 – 65.5
Intervention
61.7
52.7 – 64.8
Delta Between Average Nighttime and Average Daytime Salivary Melatonin LevelsSecondary· 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
Group
Value
95% CI
Baseline
-16.4
-28.0 – -0.1
Intervention
0.1
-5.9 – 7.5
Percentage of Study Days Where Light and Sound Were ModulatedSecondary· 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
Group
Value
95% CI
Baseline
0
0 – 0
Intervention
100
75 – 100
Percentage of Study Days Where the Patient Not Fed Enterally After BedtimeSecondary· 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
Group
Value
95% CI
Baseline
43
27 – 67
Intervention
57
38 – 100
Continuity in Nursing CareSecondary· 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.
Group
Value
95% CI
Baseline
67
52 – 77
Intervention
67
57 – 80
Pain Free DaysSecondary· 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)
Group
Value
95% CI
Baseline
80
67 – 95
Intervention
74
45 – 86
Agitation Free DaysSecondary· 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)
Group
Value
95% CI
Baseline
55
43 – 100
Intervention
50
25 – 75
Delirium Free DaysSecondary· 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)
Group
Value
95% CI
Baseline
74
50 – 100
Intervention
100
60 – 100
Iatrogenic Withdrawal Syndrome (IWS) Free DaysSecondary· 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)
Group
Value
95% CI
Baseline
100
100 – 100
Intervention
100
75 – 100
Peak Daily Dose of All Opioid Sedative AgentsSecondary· 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
Group
Value
95% CI
Baseline
3.5
1.7 – 6.1
Intervention
2.9
1.0 – 4.2
Cumulative Dose of All Opioid Sedative AgentsSecondary· 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
Group
Value
95% CI
Baseline
12.2
4.6 – 23.5
Intervention
7.6
2.2 – 18.8
Total PICU Days of Opioid SedationSecondary· 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
Group
Value
95% CI
Baseline
6
5 – 11
Intervention
7
4 – 11
Adverse events — posted to ClinicalTrials.gov
Time frame: From date of enrollment until the date of PICU discharge, assessed for up to 28 days.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Pennsylvania
Last refreshed: 30 April 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04695392.