Study of Biotene OralBalance Gel for Oral Care in Critically-Ill Mechanically Ventilated Neonates

Completed · Early Phase 1

Conditions studied: Ventilator-associated Pneumonia

In brief

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.

Key facts

Study ID

NCT01314742

Run by

Wake Forest University Health Sciences

People needed

41

Starts

2010-05-01

Expected to finish

2012-07-01

Last updated by the study team

2018-09-11

Who can join

Age: 0 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Neonates who are mechanically ventilated between 7 and 10 days old. Signed parental informed consent is required for recruitment into the study.

You may not qualify if…

• 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.

Where it is running

• Forsyth Medical Center — Winston-Salem, North Carolina, United States
• Brenner Children's Hospital — Winston-Salem, North Carolina, United States

Full record on ClinicalTrials.gov

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