CompletedEarly Phase 1

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

United States41 participantsStarted 2010-05

Plain-language 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.

Who can participate

Age range7 Days

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Feasibility

Timeframe: duration of study, for up to 30 months

Duration of Mechanical Ventilation

Timeframe: 3 days

Trial details

NCT IDNCT01314742

SponsorWake Forest University Health Sciences

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2012-01

Results submitted2013-12-16

View on ClinicalTrials.gov More Ventilator-associated Pneumonia trials