Respiratory Distress Syndrome, NewbornEarly Phase 1NCT01688440
ETCare: Safety and Preliminary Efficacy Trial
A Early Phase 1 study testing #1 Respiratory Care Solution in people with Respiratory Distress Syndrome, Newborn, run by Intermountain Health Care, Inc. at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Respiratory Distress Syndrome, Newborn
- What is being tested?
- #1 Respiratory Care Solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2005to Sep 2005
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
McKay-Dee Hospital Center
Ogden, Utah, 84403
LDS Hospital Center
Salt Lake City, Utah, 84143
About this study
Official title: "ETCare": A Phase II, 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 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.
Read more
Study Hypothesis:
- Patients who receive ETCare will have no increase in adverse events related to its administration, compared with 0.9% saline.
- Patients who receive ETCare will have a lower proportion of tracheal aspirates where pathogens are reported.
- Patients who receive ETCare will have a lower proportion of tracheal aspirates where leukocytes are reported.
- Patients who receive ETCare will have fewer (risk-adjusted) days of supplemental oxygen.
Read the detailed description
Normal saline (0.9% sodium chloride) is used by virtually all neonatal intensive care units to periodically irrigate the endotracheal tube of neonates who require mechanical ventilation. This practice is intended to reduce the risk that thick secretions will occlude the endotracheal tube. Normal saline is also occasionally used to periodically clear the nasal passages of neonates on nasal CPAP or nasal canula oxygen. It is also occasionally used as a means of periodically moistening the mouth of neonates who have an endotracheal tube in place, because the tube prevents lip apposition and results in a dry mouth.
The problem with the current method of using normal saline for periodic endotracheal, nasal, and/or oral care is that high concentrations of sodium and chloride have recently been found to rapidly and completely inactivate the natural antimicrobial properties of tracheal effluent, nasal secretions, and saliva. Tracheal secretions, nasal secretions, and saliva contain potent antibacterial substances. One such that was recently described is a 37 amino acid peptide with widespread antimicrobial properties, termed "LL-37". It has recently been shown that 0.9% saline inactivates the antimicrobial properties of LL-37 and significantly damages the overall antibacterial actions of tracheal secretions, nasal secretions, and saliva. Further research has shown that the high sodium and chloride content of saliva of patients with cystic fibrosis inactivates the antimicrobial properties, thus partly explaining the high incidence of airway infections in these patients. Moreover, a family with deficient LL-37 has been described in Sweden, and these individual all have chronic gingivostomatitis and airway infections. Therefore, our current practice of instilling 0.9% sodium chloride likely inactivates the major innate anti-microbial defense system of the upper airway. Perhaps reducing immune capacity in the upper airway with this practice unwittingly contributes to the high incidence of upper airway infections among intubated neonates.
- Conditions
- Respiratory Distress Syndrome, Newborn
- Being tested
- #1 Respiratory Care Solution
- Keywords
- Endotracheal Cares, Neonate, TAC's, Endotracheal Suctioning, Tracheal Aspirate Culture, Oral Cares, Neonate oxygen Therapy
- Medical subject headings
- Respiratory Distress Syndrome, Newborn
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
#1 Respiratory Care SolutionOther
Respiratory care solution.
| Study group | Role | What they receive |
|---|---|---|
| #1 Respiratory Care Solution | Experimental | Low sodium physiologically based airway care solution. Receives: Other: #1 Respiratory Care Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of adverse events related to administration.
Renal hematological and hepatic function.
Measured: To discharge home (about one month).
Secondary outcomes (1)
Feasibility and immediate intolerance
Desaturation, bradycardia, tachydardia, hypotension, or hypertension or skin rashes.
Measured: Day of administration (one day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2012 (estimated)
- Study startJun 2005
- Primary completionSep 2005
- Study completionSep 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Distress Syndrome, NewbornStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intermountain Health Care, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Deseret Foundation
- Responsible party
- Principal investigator, Robert D. Christensen, MD, Intermountain Health Care, Inc.
- Investigators
- Robert D. Christensen, MD, Principal investigator, Interountain Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01688440
- Sponsor's protocol ID
- 05.018
- Status last verified
- Sep 2012
- First submitted
- 12 May 2008
- Last updated
- 19 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "ETCare": A Phase II, Safety and Preliminary Efficacy Trial
- ClinicalTrials.gov ID
- NCT01688440
- Acronym / sponsor ID
- 05.018
- Conditions
- Respiratory Distress Syndrome, Newborn
- Keywords
- Endotracheal Cares, Neonate, TAC's, Endotracheal Suctioning, Tracheal Aspirate Culture, Oral Cares, Neonate oxygen Therapy
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Intermountain Health Care, Inc.University, hospital or other
- Collaborators
- Deseret Foundation
- Study start
- Jun 2005
- Primary completion
- Sep 2005 (actual)
- Study completion
- Sep 2005 (actual)
- First posted
- 19 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Patients who receive ETCare will have no increase in adverse events related to its administration, compared with 0.9% saline.
- Patients who receive ETCare will have a lower proportion of tracheal aspirates where pathogens are reported.
- Patients who receive ETCare will have a lower proportion of tracheal aspirates where leukocytes are reported.
- Patients who receive ETCare will have fewer (risk-adjusted) days of supplemental oxygen.
Detailed description
Normal saline (0.9% sodium chloride) is used by virtually all neonatal intensive care units to periodically irrigate the endotracheal tube of neonates who require mechanical ventilation. This practice is intended to reduce the risk that thick secretions will occlude the endotracheal tube. Normal saline is also occasionally used to periodically clear the nasal passages of neonates on nasal CPAP or nasal canula oxygen. It is also occasionally used as a means of periodically moistening the mouth of neonates who have an endotracheal tube in place, because the tube prevents lip apposition and results in a dry mouth.
The problem with the current method of using normal saline for periodic endotracheal, nasal, and/or oral care is that high concentrations of sodium and chloride have recently been found to rapidly and completely inactivate the natural antimicrobial properties of tracheal effluent, nasal secretions, and saliva. Tracheal secretions, nasal secretions, and saliva contain potent antibacterial substances. One such that was recently described is a 37 amino acid peptide with widespread antimicrobial properties, termed "LL-37". It has recently been shown that 0.9% saline inactivates the antimicrobial properties of LL-37 and significantly damages the overall antibacterial actions of tracheal secretions, nasal secretions, and saliva. Further research has shown that the high sodium and chloride content of saliva of patients with cystic fibrosis inactivates the antimicrobial properties, thus partly explaining the high incidence of airway infections in these patients. Moreover, a family with deficient LL-37 has been described in Sweden, and these individual all have chronic gingivostomatitis and airway infections. Therefore, our current practice of instilling 0.9% sodium chloride likely inactivates the major innate anti-microbial defense system of the upper airway. Perhaps reducing immune capacity in the upper airway with this practice unwittingly contributes to the high incidence of upper airway infections among intubated neonates.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| #1 Respiratory Care Solution | Experimental | Other: #1 Respiratory Care SolutionLow sodium physiologically based airway care solution. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| #1 Respiratory Care SolutionRespiratory care solution. | Other | #1 Respiratory Care Solution |
Primary outcome
The incidence of adverse events related to administration.
Time frame: To discharge home (about one month).
Renal hematological and hepatic function.
1 secondary outcome
Feasibility and immediate intolerance
Time frame: Day of administration (one day)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert D. Christensen, MD principal investigator
Interountain Healthcare
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing #1 Respiratory Care Solution in people with Respiratory Distress Syndrome, Newborn, run by Intermountain Health Care, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of adverse events related to administration. (time frame: To discharge home (about one month).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2012.