ETCare: Safety and Preliminary Efficacy Trial
Completed · Early Phase 1
Conditions studied: Respiratory Distress Syndrome, Newborn
In brief
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: 1. Patients who receive ETCare will have no increase in adverse events related to its administration, compared with 0.9% saline. 2. Patients who receive ETCare will have a lower proportion of tracheal aspirates where pathogens are reported. 3. Patients who receive ETCare will have a lower proportion of tracheal aspirates where leukocytes are reported. 4. Patients who receive ETCare will have fewer (risk-adjusted) days of supplemental oxygen.
Key facts
- Study ID
- NCT01688440
- Run by
- Intermountain Health Care, Inc.
- People needed
- 10
- Starts
- 2005-06-01
- Expected to finish
- 2005-09-01
- Last updated by the study team
- 2012-09-19
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Be a patient in the NICU of either McKay-Dee Hospital or LDS Hospital.
- Be <24 hrs old at the time of study entry.
- Have an endotracheal tube in place.
- Be expected, by declaration of the attending neonatologist, to have an endotracheal tube for at least the next 48 hrs.
- Have the informed consent document signed by the parent or responsible guardian
You may not qualify if…
- They have what the attending neonatologist judges to be a "lethal" congenital abnormality.
- They have a condition that is likely (by judgment of the attending neonatologist) to require transfer to Primary Children's Medical Center before the endotracheal tube has been electively removed.
Where it is running
- McKay-Dee Hospital Center — Ogden, Utah, United States
- LDS Hospital Center — Salt Lake City, Utah, United States
Full record on ClinicalTrials.gov
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