Status:
COMPLETED
Sedation Management in Pediatric Patients With Acute Respiratory Failure (The RESTORE Study)
Lead Sponsor:
University of Pennsylvania
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Respiratory Insufficiency
Respiratory Distress Syndrome, Newborn
Eligibility:
All Genders
2-18 years
Phase:
PHASE3
Brief Summary
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...
Detailed Description
People who are hospitalized for acute respiratory failure are typically supported on mechanical ventilation, which delivers oxygen and a continuous level of pressure to the damaged lungs. Over 90% of ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
2449 Patients enrolled
Trial Details
Trial ID
NCT00814099
Start Date
January 1 2009
End Date
December 1 2013
Last Update
July 15 2015
Active Locations (31)
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1
Children's Hospital of Alabama
Birmingham, Alabama, United States, 35233
2
University Medical Center, The University of Arizona
Tucson, Arizona, United States, 85724
3
Children's Hospital and Research Center at Oakland
Oakland, California, United States, 94609-1809
4
Children's Hospital of Orange County
Orange, California, United States, 92868