A pilot study of Biotene OralBalance® gel for oral care in mechanically ventilated preterm neonates

Abstract

Background: Neonatal ventilator-associated pneumonia (VAP) is associated with increased morbidity and mortality. In adults on mechanical ventilation, timed oral care decreases the frequency of VAP, but this approach has not been studied in neonates.

Objectives: To evaluate the feasibility of a randomized trial of timed oral care with Biotene OralBalance® gel and estimate the required sample size for such a trial.

Methods: Infants were eligible for enrollment if they were born before 28 weeks of gestation, and were mechanically ventilated between 7 and 10 postnatal days. Infants were randomized to receive timed oral care with Biotene OralBalance® gel or sterile water. All subjects were treated with a standard bundle of procedures to reduce the risk of VAP.

Results: We enrolled 41 of 46 eligible infants (89%). Compliance with timed oral care protocol was 97%. No local oral side effects of Biotene OralBalance® gel were observed. There were no significant group differences in mortality or short-term outcomes, except length of hospital stay which was significantly shorter in the Sterile water group (p = 0.02). A lower rate of VAP was found in the Biotene group, although the difference was not statistically significant (9/1000 ventilator-days versus 17/1000 ventilator-days in the Sterile water group, respectively; p = 0.16).

Conclusions: The results of this pilot study support the feasibility of a randomized trial of timed oral care with Biotene OralBalance® gel for prevention of VAP in mechanically ventilated neonates.

Trial registration: ClinicalTrials.gov NCT01314742.

Keywords: CDC; Center of Diseases Control and Prevention; ELBW; Mechanical ventilation; NHSN; National Healthcare Safety Network; Pilot study; Preterm infants; VAP; VAP (ventilator-associated pneumonia); extremely low birth weight; ventilator-associated pneumonia.