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ETCare: Safety and Preliminary Efficacy Trial
NCT01688440 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- OTHER #1 Respiratory Care Solution
Study Locations (2)
Utah
- McKay-Dee Hospital Center — Ogden
- LDS Hospital Center — Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2005-06 |
| Est. Completion | 2005-09 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01688440
The ClinicalTrials.gov registry entry for NCT01688440 describes a study currently listed as completed. It is categorized as Early Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Intermountain Health Care, which has 58 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Respiratory Distress Syndrome, Newborn appearing as the primary indexed condition, and to 1 intervention — of which #1 Respiratory Care Solution is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01688440 reports 2 study locations spanning 1 distinct geographic area — top geographies include Utah. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT01688440 about?
NCT01688440 is a clinical study titled "ETCare: Safety and Preliminary Efficacy Trial". 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 effect...
What is the current status of trial NCT01688440?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 10 participants. The study started on 2005-06. Estimated completion is 2005-09.
What conditions does trial NCT01688440 study?
This clinical trial studies the following conditions: Respiratory Distress Syndrome, Newborn. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01688440?
The interventions under investigation include: #1 Respiratory Care Solution (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01688440?
This trial is sponsored by Intermountain Health Care, which has 58 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT01688440 being conducted?
This trial has 2 study locations across Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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