Status:
SUSPENDED
Effects of Volume Guarantee With Pressure Supported vs. Synchronized Intermittent Mandatory Ventilation in VLBW Infants
Lead Sponsor:
Children's Hospitals and Clinics of Minnesota
Collaborating Sponsors:
Windtree Therapeutics
Conditions:
Respiratory Distress Syndrome
Eligibility:
All Genders
72-120 years
Brief Summary
Studies in preterm infants have shown that adding volume guarantee (VG) to synchronized modes of ventilation is not only feasible but also advantageous for providing more constant and desirable mechan...
Detailed Description
After informed consent is obtained, each patient will be started on the study between 72 to 96 hours of age. Each infant will be assigned via block randomization to an initial ventilation mode (PSV+VG...
Eligibility Criteria
Inclusion
- Infants will be recruited based on the following criteria: weight ≤1500 grams and need for mechanical ventilation at 72 - 120 hours of age. Recruitment will continue until 16 patients have completed the study
Exclusion
- Exclusion criteria include significant endotracheal tube leak (\>30% leak does not allow for accurate measurement of ventilator data), use of narcotic drip medication, use of paralytic medication, use of inhaled nitric oxide, fraction of inspired oxygen (FiO2) \>70% at the time of enrollment, or significant congenital defects of any organ system (e.g. cardiac, respiratory, CNS).
Key Trial Info
Start Date :
February 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2007
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00295230
Start Date
February 1 2006
End Date
September 1 2007
Last Update
November 7 2007
Active Locations (1)
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1
Children's Hospitals and Clinics of Minnesota
Minneapolis, Minnesota, United States, 55404