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

Prolonged mechanical ventilation is a known risk factor strongly associated with
ventilator-associated pneumonia (VAP). As the fatality rates for VAP are high, prevention of
VAP has focused on the use of "VAP bundles". Oral decontamination, by reducing the microbial
burden within a patient's oral cavity, is an essential part of VAP bundle strategy for
reducing VAP rates in mechanically ventilated adults and older children. However there are no
published studies of oral care products for VAP prevention in mechanically ventilated
neonates. Biotene OralBalance® gel contains antibacterial active ingredients, including
lactoperoxidase, lysozyme and lactoferrin,all enzymes with bacteriostatic or bactericidal
activity on selective oral microflora. We hypothesize that by directly reducing the oral
microbial burden, we indirectly reduce the number of VAP. This will be reflected in the
reduced time on mechanical ventilation in the group of infants receiving Biotene OralBalance®
gel.

This is a prospective, randomized, unmasked, controlled trial with 40 mechanically ventilated
infants recruited from level IV nursery at Forsyth Medical Center, Winston-Salem, NC. The
participants will be randomized to two equal groups, stratified by gestational age
categories: <28 weeks, and >=28 weeks as well as multiple births. Twenty infants will receive
Biotene OralBalance® gel (Intervention Group) and 20 infants will receive swabs with sterile
water (Control Group) for timed oral care. Both study groups will receive the NICU standard
ventilator-associated pneumonia (VAP) bundle, a combination of strategies aimed to reduce the
rate of VAP.

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.