Early Phase 1
Completed N=41
Study of Biotene OralBalance Gel for Oral Care in Critically-Ill Mechanically Ventilated Neonates
Source: ClinicalTrials.gov NCT01314742 ↗Enrolled (actual)
41
Serious AEs
0.0%
Results posted
Feb 2014
Primary outcomePrimary: Feasibility — 100; 100 percentage of participants retained
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Feasibility |
100; 100 | — |
| PRIMARY Duration of Mechanical Ventilation |
32; 30 | — |
Eligibility Criteria
Inclusion Criteria
- Neonates who are mechanically ventilated between 7 and 10 days old. Signed parental informed consent is required for recruitment into the study.
Exclusion Criteria
- Neonates with chromosomal anomalies or major congenital anomalies, neonates with terminal conditions, neonates for whom a decision has been made not to provide full medical support, neonates whose parents refused or are unable to provide consent, and/or attending physician refusal.
Data sourced from ClinicalTrials.gov (NCT01314742). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.