An Early Phase 1 interventional study of #1 Respiratory Care Solution in Respiratory Distress Syndrome, Newborn, sponsored by Intermountain Health Care, Inc.. Completed at 2 sites in United States. Per ClinicalTrials.gov, last updated 2012-09-19.
Sponsored by Intermountain Health Care, Inc. · Early Phase 1, Interventional, and Prevention
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:
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.
1,597 studies on the registry are indexed under Respiratory Distress Syndrome; 312 are open to participants now.
This study's enrollment of 10 is below the median of 60 across 961 interventional studies indexed under Respiratory Distress Syndrome.
Browse Respiratory Distress Syndrome studies →Intermountain Health Care, Inc. is the lead sponsor of 118 studies on the registry; 15 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 3 (33%) have results posted.
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Exclusion Criteria:
Low sodium physiologically based airway care solution.
Other: #1 Respiratory Care Solution
Respiratory care solution.
The incidence of adverse events related to administration.
Renal hematological and hepatic function.
Time frame: To discharge home (about one month).
Feasibility and immediate intolerance
Desaturation, bradycardia, tachydardia, hypotension, or hypertension or skin rashes.
Time frame: Day of administration (one day)
This study is completed, as verified in Sep 2012. You cannot join it, but the record below documents what was studied.
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Intermountain Health Care, Inc.