Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01688440 · ClinicalTrials.gov registry record · Early Phase 1
ETCare: Safety and Preliminary Efficacy Trial
A Early Phase 1 study of Respiratory Distress Syndrome, Newborn, sponsored by Intermountain Health Care.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 10
- Enrollment target
- 2
- Study locations
NCT01688440 is a Early Phase 1 study of Respiratory Distress Syndrome, Newborn that has completed, run by Intermountain Health Care. The registered enrollment target is 10 participants, below the 207-participant average among 8 other Respiratory Distress Syndrome, Newborn trials with a reported enrollment target (95% lower). The trial reports 2 study locations across 1 state.
The verdict
NCT01688440, a Early Phase 1 study of Respiratory Distress Syndrome, Newborn, has completed, sponsored by Intermountain Health Care.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 10 participants
- Enrollment target
- 2
- Study locations
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 |
Interested in This Trial?
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, categorized as Early Phase 1. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 207-participant average among 8 other Respiratory Distress Syndrome, Newborn trials with a reported enrollment target (95% lower). The listed sponsor is Intermountain Health Care, which has 85 total studies on file at ClinicalTrials.gov.
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.
NCT01688440 reports 2 study locations spanning 1 distinct geographic area - top geographies include Utah.
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.
What interventions are being tested in trial NCT01688440?
The interventions under investigation include: #1 Respiratory Care Solution (OTHER).
Who is sponsoring clinical trial NCT01688440?
This trial is sponsored by Intermountain Health Care, which has 85 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Respiratory Distress Syndrome, Newborn
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Predicting the Need for Prolonged Respiratory Support in Neonates Delivered in a Lower-Level NICU Setting
RECRUITING
-
Echography-guided Surfactant THERapy (ESTHER) For Preterm Infants With Respiratory Failure
RECRUITING · NA
-
Prophylactic Minimally Invasive Surfactant Evaluation
RECRUITING · Phase 4
-
Pulmonary Function Using Non-invasive Forced Oscillometry
ACTIVE NOT RECRUITING · NA
-
Aerosolized Surfactant in Neonatal RDS
COMPLETED · Phase 1
-
Work of Breathing During Non-invasive Ventilation in Premature Neonates
COMPLETED · NA
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.