ETCare: Safety and Preliminary Efficacy Trial
"ETCare": A Phase II, Safety and Preliminary Efficacy Trial
"ETCare": A Phase II, Safety and Preliminary Efficacy Trial
Sponsor study identifier
interventional
10
1 country
2
Study Start
June 2005
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
September 2005
Actual (reported)Study Completion
September 2005
Actual (reported)When babies are sick, or are born prematurely, they sometimes need an endotracheal (ET) tube to assist their breathing and/or a nasal canula. The investigators must periodically irrigate the ET tube to prevent them from being plugged up by secretions. The investigators also, due to the drying effects of nasal canula, periodically moisten the nasal passages of babies. Presently 0.9% saline is the solution being used for moistening of the ET tube, nose, as well as oral cares will infant is not eating. However, scientists have recently learned that saline can destroy the body's natural antibacterial properties in the windpipe, nose, and mouth. The investigators have developed a new solution to be used in place of saline for endotracheal (ET), nasal, and oral cares. The investigators' new solution is patterned after the natural fluid in the windpipe, nose, and mouth. Study Hypothesis:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2005
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 2005
Date type not reportedThis date has not been verified as actual or estimated.
September 2005
Actual (reported)September 2005
Actual (reported)May 12, 2008
Actual (reported)September 19, 2012
Actual (reported)The incidence of adverse events related to administration.
Renal hematological and hepatic function.
To discharge home (about one month).
Feasibility and immediate intolerance
Day of administration (one day)
Low sodium physiologically based airway care solution.
Respiratory care solution.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
McKay-Dee Hospital Center
Ogden, Utah, 84403, United States
LDS Hospital Center
Salt Lake City, Utah, 84143, United States
Robert D. Christensen, MD
Interountain Healthcare
10 participants (actual enrollment reported by the registry).
First Submitted
May 12, 2008
First Posted
September 19, 2012
Study Start
June 2005
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
September 2005
Actual (reported)Study Completion
September 2005
Actual (reported)Last Updated
September 19, 2012
Record last verified: 2012-09
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Source: ClinicalTrials.gov.
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