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ETCare: Safety and Preliminary Efficacy Trial

NCT01688440 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2012-09-19

No results posted yet for this 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

  • Respiratory Distress Syndrome, Newborn

Interventions

OTHER

#1 Respiratory Care Solution

Respiratory care solution.

Sponsors & Collaborators

  • Deseret Foundation

    collaborator OTHER

  • Intermountain Health Care, Inc.

    lead OTHER

Principal Investigators

  • Robert D. Christensen, MD · Interountain Healthcare

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-06-30
Primary Completion
2005-09-30
Completion
2005-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01688440 on ClinicalTrials.gov