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Team sedation strategy may shorten ventilator time for kids

NCT ID NCT00814099

Symptom relief Sponsor: University of Pennsylvania Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a team-based approach to managing sedation in children with acute respiratory failure who need a breathing machine. The goal was to reduce the number of days on the ventilator. Over 2,400 children from multiple hospitals participated, comparing the team approach to usual care.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
team approach to sedation management
What this could lead to
If successful, this approach could shorten the time children need a breathing machine, reducing hospital stays and risks.
What could go wrong
This is a completed study, so results are known. The approach may not work for all children or in all hospitals.

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

2,449 people

The number who actually took part.

Start date

Jan 2009

Finished

Dec 2013

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

2 weeks to 18 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: * At least 2 weeks of age (and at least 42 weeks post-menstrual age) and less than 18 years of age * Intubated and mechanically ventilated for acute lung disease Exclusion Criteria: * Cyanotic heart disease with unrepaired or palliated right to left intracardiac shunt * History of single ventricle at any stage of repair * Congenital diaphragmatic hernia or paralysis * Primary pulmonary hypertension * Critical airway or anatomical obstruction of the lower airway * Ventilator dependent upon pediatric ICU admission * Neuromuscular respiratory failure * Spinal cord injury above the lumbar region * Pain managed by patient-controlled analgesia or epidural catheter * Patient transferred from an outside ICU where sedatives had already been administered for more than 24 hours * Family or medical team has decided not to provide full support * Enrolled in any other critical care interventional clinical trial concurrently or in the 30 days before study entry * Known allergy to any of the study medications * Pregnancy

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Conditions

The condition(s) this trial relates to.

acute lung injury acute respiratory failure lung disorder newborn respiratory distress syndrome Respiratory Distress Syndrome, Newborn respiratory failure

As listed by the trial registrant

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

Lung diseases Respiratory distress syndrome, newborn Respiratory insufficiency

Contacts and locations

Locations

  • Advocate Hope Children's Hospital

    Oak Lawn, Illinois, 60453, United States

  • C. S. Mott Children's Hospital of the University of Michigan

    Ann Arbor, Michigan, 48109-0243, United States

  • Children's Hospital and Research Center at Oakland

    Oakland, California, 94609-1809, United States

  • Children's Hospital at University of California San Francisco Medical Center

    San Francisco, California, 94143, United States

  • Children's Hospital of Alabama

    Birmingham, Alabama, 35233, United States

  • Children's Hospital of Orange County

    Orange, California, 92868, United States

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104, United States

  • Children's Medical Center Dallas

    Dallas, Texas, 75235, United States

  • Children's Memorial Hospital, Chicago

    Chicago, Illinois, 60614-3363, United States

  • Children's Mercy Hospital, Kansas City

    Kansas City, Missouri, 84108, United States

  • Cohen Children's Medical Center of New York

    New Hyde Park, New York, 11040, United States

  • Connecticut Children's Medical Center

    Hartford, Connecticut, 06106, United States

  • Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03756-0001, United States

  • Doernbecher Children's Hospital

    Portland, Oregon, 97239, United States

  • Duke Children's Hospital and Health Center

    Durham, North Carolina, 27710, United States

  • Florida Hospital for Children

    Orlando, Florida, 32803, United States

  • Holtz Children's Hospital

    Miami, Florida, 33136, United States

  • Johns Hopkins Children's Center

    Baltimore, Maryland, 21287, United States

  • Lucile Salter Packard Children's Hospital at Stanford

    Palo Alto, California, 94304-0126, United States

  • Medical City Children's Hospital

    Dallas, Texas, 75230, United States

  • Monroe Carell, Jr. Children's Hospital at Vanderbilt

    Nashville, Tennessee, 37232-9075, United States

  • Nemours/Alfred I. duPont Hospital for Children

    Wilmington, Delaware, 19803, United States

  • Primary Children's Medical Center

    Salt Lake City, Utah, 84113, United States

  • St. Louis Children's Hospital

    St Louis, Missouri, 63110, United States

  • The Children's Hospital at Montefiore

    The Bronx, New York, 10467, United States

  • University Medical Center, The University of Arizona

    Tucson, Arizona, 85724, United States

  • University of California Davis Medical Center

    Sacramento, California, 95817, United States

  • University of Maryland Hospital for Children

    Baltimore, Maryland, 21201-1595, United States

  • University of Massachusetts Memorial Children's Medical Center

    Worcester, Massachusetts, 01655, United States

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68114, United States

  • Yale-New Haven Children's Hospital

    New Haven, Connecticut, 06520-8064, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.