NCT01688440

Brief 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. 1.Patients who receive ETCare will have no increase in adverse events related to its administration, compared with 0.9% saline.
  2. 2.Patients who receive ETCare will have a lower proportion of tracheal aspirates where pathogens are reported.
  3. 3.Patients who receive ETCare will have a lower proportion of tracheal aspirates where leukocytes are reported.
  4. 4.Patients who receive ETCare will have fewer (risk-adjusted) days of supplemental oxygen.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for early_phase_1

Timeline
Completed

Started Jun 2005

Shorter than P25 for early_phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2005

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

May 12, 2008

Completed
4.4 years until next milestone

First Posted

Study publicly available on registry

September 19, 2012

Completed
Last Updated

September 19, 2012

Status Verified

September 1, 2012

Enrollment Period

3 months

First QC Date

May 12, 2008

Last Update Submit

September 18, 2012

Conditions

Respiratory Distress Syndrome, Newborn

Keywords

Endotracheal CaresNeonateTAC'sEndotracheal SuctioningTracheal Aspirate CultureOral CaresNeonate oxygen Therapy

Outcome Measures

Primary Outcomes (1)

  • The incidence of adverse events related to administration.

    Renal hematological and hepatic function.

    To discharge home (about one month).

Secondary Outcomes (1)

  • Feasibility and immediate intolerance

    Day of administration (one day)

Study Arms (1)

#1 Respiratory Care Solution

EXPERIMENTAL

Low sodium physiologically based airway care solution.

Other: #1 Respiratory Care Solution

Interventions

#1 Respiratory Care SolutionOTHER

Respiratory care solution.

#1 Respiratory Care Solution

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

McKay-Dee Hospital Center

Ogden, Utah, 84403, United States

Location

LDS Hospital Center

Salt Lake City, Utah, 84143, United States

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome, Newborn

Condition Hierarchy (Ancestors)

Respiratory Distress SyndromeLung DiseasesRespiratory Tract DiseasesRespiration DisordersInfant, Premature, DiseasesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Robert D. Christensen, MD

    Interountain Healthcare

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Neonatology Research

Study Record Dates

First Submitted

May 12, 2008

First Posted

September 19, 2012

Study Start

June 1, 2005

Primary Completion

September 1, 2005

Study Completion

September 1, 2005

Last Updated

September 19, 2012

Record last verified: 2012-09

Locations

US(2)