Sedation Management in Pediatric Patients With Acute Respiratory Failure (The RESTORE Study)

Completed · Not applicable

Conditions studied: Respiratory Insufficiency, Respiratory Distress Syndrome, Newborn, Lung Diseases

In brief

People with acute respiratory failure usually require the use of an artificial breathing machine, known as a mechanical ventilator. Sedative medications, which help keep people calm and reduce anxiety, are often prescribed for children who are on mechanical ventilators. However, the longer that sedative medications are used, the longer a child may need to remain on mechanical ventilation. This study will evaluate the effectiveness of a team approach to sedation management that aims to reduce the number of days that children with acute respiratory failure require mechanical ventilation.

Key facts

Study ID

NCT00814099

Run by

University of Pennsylvania

People needed

2449

Starts

2009-01-01

Expected to finish

2013-12-01

Last updated by the study team

2026-05-01

Who can join

Age: 0 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Children's Hospital of Alabama — Birmingham, Alabama, United States
• University Medical Center, The University of Arizona — Tucson, Arizona, United States
• Children's Hospital and Research Center at Oakland — Oakland, California, United States
• Children's Hospital of Orange County — Orange, California, United States
• Lucile Salter Packard Children's Hospital at Stanford — Palo Alto, California, United States
• University of California Davis Medical Center — Sacramento, California, United States
• Children's Hospital at University of California San Francisco Medical Center — San Francisco, California, United States
• Connecticut Children's Medical Center — Hartford, Connecticut, United States
• Yale-New Haven Children's Hospital — New Haven, Connecticut, United States
• Nemours/Alfred I. duPont Hospital for Children — Wilmington, Delaware, United States
• Holtz Children's Hospital — Miami, Florida, United States
• Florida Hospital for Children — Orlando, Florida, United States
• Children's Memorial Hospital, Chicago — Chicago, Illinois, United States
• Advocate Hope Children's Hospital — Oak Lawn, Illinois, United States
• University of Maryland Hospital for Children — Baltimore, Maryland, United States
• Johns Hopkins Children's Center — Baltimore, Maryland, United States
• University of Massachusetts Memorial Children's Medical Center — Worcester, Massachusetts, United States
• C. S. Mott Children's Hospital of the University of Michigan — Ann Arbor, Michigan, United States
• Children's Mercy Hospital, Kansas City — Kansas City, Missouri, United States
• St. Louis Children's Hospital — St Louis, Missouri, United States
• University of Nebraska Medical Center — Omaha, Nebraska, United States
• Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States
• Cohen Children's Medical Center of New York — New Hyde Park, New York, United States
• The Children's Hospital at Montefiore — The Bronx, New York, United States
• Duke Children's Hospital and Health Center — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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