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Restore Resilience in Critically Ill Children

NCT04695392 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2026-05-11

Study results available
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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.

Conditions

  • Acute Respiratory Distress Syndrome

Interventions

OTHER

R2 Bundle

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.

Sponsors & Collaborators

Principal Investigators

  • Martha AQ Curley, RN, PhD · University of Pennsylvania

Study Design

Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-05
Primary Completion
2021-12-31
Completion
2021-12-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04695392 on ClinicalTrials.gov