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NCT01314742 · ClinicalTrials.gov registry record · Early Phase 1
Study of Biotene OralBalance Gel for Oral Care in Critically-Ill Mechanically Ventilated Neonates
A Early Phase 1 study of Ventilator Associated Pneumonia, sponsored by Wake Forest University Health Sciences.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 41
- Enrollment target
- 2
- Study locations
NCT01314742: Completed Early Phase 1 study of Ventilator Associated Pneumonia, sponsored by Wake Forest University Health Sciences.
NCT01314742 is a Early Phase 1 study of Ventilator Associated Pneumonia that has completed, run by Wake Forest University Health Sciences. The registered enrollment target is 41 participants, below the 110-participant average among 7 other Ventilator Associated Pneumonia trials with a reported enrollment target (63% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01314742, a Early Phase 1 study of Ventilator Associated Pneumonia, has completed, sponsored by Wake Forest University Health Sciences.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 41 participants
- Enrollment target
- 2
- Study locations
Study Summary
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.
Primary Outcome
percentage of participants with retention
Conditions Studied
Interventions
- DRUG Biotene OralBalance® gel
- OTHER Sterile Water moisten cotton tipped applicator
Study Locations (2)
North Carolina
- Forsyth Medical Center - Winston-Salem
- Brenner Children's Hospital - Winston-Salem
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 41 participants |
| Start Date | 2010-05 |
| Est. Completion | 2012-07 |
| Phase | Early Phase 1 |
What the finished NCT01314742 record still lists
NCT01314742 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 41 participants, a relatively small participant target, below the 110-participant average among 7 other Ventilator Associated Pneumonia trials with a reported enrollment target (63% lower).
The record links to 1 condition, with Ventilator Associated Pneumonia appearing as the primary indexed condition, and to 2 interventions - of which Biotene OralBalance® gel is the first listed.
NCT01314742 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT01314742 about?
NCT01314742 is a clinical study titled "Study of Biotene OralBalance Gel for Oral Care in Critically-Ill Mechanically Ventilated Neonates". 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 o...
What is the current status of trial NCT01314742?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 41 participants. The study started on 2010-05. Estimated completion is 2012-07.
What conditions does trial NCT01314742 study?
This clinical trial studies the following conditions: Ventilator Associated Pneumonia.
What interventions are being tested in trial NCT01314742?
The interventions under investigation include: Biotene OralBalance® gel (DRUG), Sterile Water moisten cotton tipped applicator (OTHER).
Who is sponsoring clinical trial NCT01314742?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01314742 being conducted?
This trial has 2 study locations across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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