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A Randomized Controlled Clinical Trial of Two Different Oral Care Regimens Combined With Ventilator-Associated Pneumonia (VAP) Bundle Strategy for Reduction of Duration of Mechanical Ventilation in a Neonatal Population
The goal of this pilot study is to test the hypothesis that mechanically ventilated infants receiving Biotene OralBalance® gel for oral care would have a reduced intubation time compared to infants receiving oral care placebo. This study is also performed to test the feasibility as well the safety of Biotene OralBalance® gel.
Details
| Lead sponsor | Wake Forest University Health Sciences |
|---|---|
| Phase | EARLY_PHASE1 |
| Status | COMPLETED |
| Enrolment | 41 |
| Start date | 2010-05 |
| Completion | 2012-07 |
Conditions
- Ventilator-associated Pneumonia
Interventions
- Biotene OralBalance® gel
- Sterile Water moisten cotton tipped applicator
Primary outcomes
- Feasibility — duration of study, for up to 30 months
percentage of participants with retention - Duration of Mechanical Ventilation — 3 days
Time on invasive mechanical ventilation will be measured in days
Countries
United States