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Can better sleep help kids in the ICU recover faster?

NCT ID NCT04695392

Knowledge-focused Sponsor: University of Pennsylvania Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at ways to improve the care, environment, and daily routines of children in the pediatric intensive care unit (PICU) to support their healing and natural sleep-wake cycles. Researchers observed 56 children aged 6 months to 18 years who were on breathing machines. The goal was to understand what helps or hinders these improvements, not to test a new treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

56 people

The number who actually took part.

Started

Sep 2017

Finished

Dec 2021

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

6 months to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

acute respiratory distress syndrome adult acute respiratory distress syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute respiratory distress syndrome

Contacts and locations

Locations

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104, United States

  • Johns Hopkins University - Charlotte Bloomberg Children's Center

    Baltimore, Maryland, 21287, United States

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