CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 56 enrolled
Drug / intervention
R2 Bundleother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04695392
NCT04695392N/ACompleted
CompareCT.gov

Restore Resilience in Critically Ill Children

University of Pennsylvania·interventional·Posted Jan 5, 2021·Updated May 11, 2026

In Brief

A clinical study evaluating R2 Bundle for Acute Respiratory Distress Syndrome. Completed, enrolled 56 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Respiratory Distress Syndrome
CountriesUnited States
CollaboratorsJohns Hopkins University, Children's Hospital of Philadelphia, Boston Children's Hospital

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedJan 5, 2021
Enrollment StartSep 5, 2017
Primary CompletionDec 31, 2021
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 5.5 years ago

Interventions

R2 Bundleother

During the intervention phase subjects will receive R2. 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.