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

Wake Forest University (WFU)

Status and phase: Completed; Early Phase 1

Conditions: Ventilator-associated Pneumonia

Treatments: Drug: Biotene OralBalance® gel; Other: Sterile Water moisten cotton tipped applicator

Study type: Interventional

Funder types: Other

Identifiers

NCT01314742

IRB00013036

FMC 2010-100 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 41 patients

Sex: All

Ages: 7+ days old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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41 participants in 2 patient groups, including a placebo group

Biotene OralBalance® gel Arm

Experimental group

Description:

Biotene OralBalance® gel contains antibacterial active ingredients: lactoperoxidase, lysozyme and lactoferrin. These enzymes occur naturally in the human milk and colostrum and have mimicking properties of the human saliva activity in vivo.

Treatment:

Drug: Biotene OralBalance® gel

Sterile Water Arm

Placebo Comparator group

Description:

Sterile Water moisten cotton tipped applicator

Treatment:

Other: Sterile Water moisten cotton tipped applicator