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Sponsors and Collaborators: |
University of Virginia ONY |
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Information provided by: | University of Virginia |
ClinicalTrials.gov Identifier: | NCT00599651 |
In this protocol we will conduct a randomized controlled trial where babies with respiratory distress syndrome (RDS) who have not yet reached criteria for intubation, will be randomized to receive surfactant by LMA or to continue receiving standard therapy of nasal CPAP and supplemental oxygen. All babies will be given surfactant by endotracheal tube if they reach "failure" criteria, which is the standard criterion for surfactant administration (i.e., FiO2= 65% while receiving nasal CPAP).
The objective of this RCT is to determine if surfactant can be successfully administered by LMA, thus perhaps avoiding the need for endotracheal intubation. The hypothesis is that fewer babies in the LMA group would reach failure criteria.
Condition | Intervention |
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Respiratory Distress Syndrome, Newborn |
Device: Surfactant administered via Laryngeal Mask Airway (LMA) Other: standard of care (nasal CPAP and supplemental oxygen) |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Randomized Controlled Trial of Surfactant Administration by Laryngeal Mask Airway (LMA) |
Estimated Enrollment: | 380 |
Study Start Date: | June 2005 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Surfactant by LMA
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Device: Surfactant administered via Laryngeal Mask Airway (LMA)
Standard volume of Infasurf surfactant (3 mL/kg) will be injected in 2-4 aliquots into the proximal end of the LMA.
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2
Standard of care
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Other: standard of care (nasal CPAP and supplemental oxygen)
Standard of care will be utilized which may mean surfactant is administered
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Ages Eligible for Study: | up to 72 Hours |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: John Kattwinkel, MD | 434-924-5428 | jk3f@virginia.edu |
Contact: Marci Williams, RN | 434-982-0263 | mar6z@virginia.edu |
United States, Virginia | |
University of Virginia | Recruiting |
Charlottesville, Virginia, United States, 22908 | |
Contact: John Kattwinkel, MD 434-924-5428 jk3f@virginia.edu | |
Contact: Marci Williams, RN 434-982-0263 mar6z@virginia.edu | |
Principal Investigator: John Kattwinkel, MD |
Principal Investigator: | John Kattwinkel, MD | University of Virginia |
Responsible Party: | University of Virginia ( John Kattwinkel, MD ) |
Study ID Numbers: | 11851 |
Study First Received: | December 29, 2007 |
Last Updated: | August 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00599651 |
Health Authority: | United States: Institutional Review Board |
Respiratory Distress Syndrome Newborn RDS |
Respiratory Tract Diseases Lung Diseases Respiration Disorders Respiratory Distress Syndrome, Adult Respiratory Distress Syndrome, Newborn |
Infant, Newborn, Diseases Acute respiratory distress syndrome Infant, Premature, Diseases Calfactant |
Pathologic Processes Disease Syndrome |