N/A
N=56
Restore Resilience in Critically Ill Children
Acute Respiratory Distress Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT04695392 ↗Enrolled (actual)
56
Serious AEs
0.0%
Results posted
Apr 2024
Primary outcome: Primary: DARE (Daytime Activity Ratio Estimate), Post Extubation — 56.7; 61.7 Percentage of total activity
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- R2 Bundle (Other)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- University of Pennsylvania
- Primary completion
- Dec 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY DARE (Daytime Activity Ratio Estimate), Post Extubation |
56.7; 61.7 | — |
| SECONDARY Delta Between Average Nighttime and Average Daytime Salivary Melatonin Levels |
-16.4; 0.1 | — |
| SECONDARY Percentage of Study Days Where Light and Sound Were Modulated |
0; 100 | — |
| SECONDARY Percentage of Study Days Where the Patient Not Fed Enterally After Bedtime |
43; 57 | — |
| SECONDARY Continuity in Nursing Care |
67; 67 | — |
| SECONDARY Pain Free Days |
80; 74 | — |
| SECONDARY Agitation Free Days |
55; 50 | — |
| SECONDARY Delirium Free Days |
74; 100 | — |
| SECONDARY Iatrogenic Withdrawal Syndrome (IWS) Free Days |
100; 100 | — |
| SECONDARY Peak Daily Dose of All Opioid Sedative Agents |
3.5; 2.9 | — |
| SECONDARY Cumulative Dose of All Opioid Sedative Agents |
12.2; 7.6 | — |
| SECONDARY Total PICU Days of Opioid Sedation |
6; 7 | — |
| SECONDARY PICU Length of Stay |
7.0; 7.1 | — |
| SECONDARY Parent Perception of Being well-cared-for |
100; 100 | — |
| SECONDARY DARE (Daytime Activity Ratio Estimate), Acute Phase |
53.3; 62.0 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT04695392). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.