Restore Resilience in Critically Ill Children

NCT04695392 | Completed Results

• 1 other identifier: 828061
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 2

Brief 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

Outcome Measures

Primary Outcomes (1)

• DARE (Daytime Activity Ratio Estimate), Post Extubation

  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.

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

Secondary Outcomes (14)

• Delta Between Average Nighttime and Average Daytime Salivary Melatonin Levels

  Day 5 of PICU hospitalization

• Percentage of Study Days Where Light and Sound Were Modulated

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

• Percentage of Study Days Where the Patient Not Fed Enterally After Bedtime

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

• Continuity in Nursing Care

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

• Pain Free Days

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

Study Arms (2)

Intervention

EXPERIMENTAL

R2 Bundle

Other: R2 Bundle

Baseline

NO INTERVENTION

Usual care

Interventions

R2 Bundle OTHER

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.

Intervention

Eligibility Criteria

• Age: 6 Months - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pennsylvania: lead
• Johns Hopkins University: collaborator
• Children's Hospital of Philadelphia: collaborator
• Boston Children's Hospital: collaborator

Study Sites (2)

Johns Hopkins University - Charlotte Bloomberg Children's Center

Baltimore, Maryland, 21287, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (3)

• Perry MA, Dawkins-Henry OS, Awojoodu RE, Blumenthal J, Asaro LA, Wypij D, Kudchadkar SR, Zuppa AF, Curley MAQ. Study protocol for a two-center test of a nurse-implemented chronotherapeutic restoring bundle in critically ill children: RESTORE Resilience (R2). Contemp Clin Trials Commun. 2021 Aug 19;23:100840. doi: 10.1016/j.conctc.2021.100840. eCollection 2021 Sep.

  PMID: 34466711 BACKGROUND

• Curley MAQ, Dawkins-Henry OS, Kalvas LB, Perry-Eaddy MA, Georgostathi G, Yuan I, Wypij D, Asaro LA, Zuppa AF, Kudchadkar SR. The Nurse-Implemented Chronotherapeutic Bundle in Critically Ill Children, RESTORE Resilience (R 2 ): Pilot Testing in a Two-Phase Cohort Study, 2017-2021. Pediatr Crit Care Med. 2024 Nov 1;25(11):1051-1064. doi: 10.1097/PCC.0000000000003595. Epub 2024 Aug 12.

  PMID: 39133067 RESULT

• Kalvas LB, Dawkins-Henry OS, Ordway MR, Kudchadkar SR, Asaro LA, Wypij D, Curley MAQ. Sleep Health in Critically Ill Children With Acute Respiratory Failure. AACN Adv Crit Care. 2026 Mar 15;37(1):107-121. doi: 10.4037/aacnacc2026606.

  PMID: 41758709 DERIVED

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Results Point of Contact

• Title: Martha A.Q. Curley, RN, PhD
• Organization: UPENN

curley@nursing.upenn.edu

2155739449

Study Officials

• Martha AQ Curley, RN, PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Pre-post study

Study Record Dates

• First Submitted: December 22, 2020
• First Posted: January 5, 2021
• Study Start: September 5, 2017
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: May 11, 2026
• Results First Posted: April 30, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)