Ventilator-associated Pneumonia
Conditions
Keywords
neonates, mechanical ventilation, oral care, duration of mechanical ventilation, feasibility, ventilator-associated pneumonia
Brief 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.
Detailed 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.
Interventions
DRUGBiotene OralBalance® gel
Biotene OralBalance® gel is dispensed as 42gm, patient specific tube from hospital's Central Pharmacy. One pea-size oral application every 4 hours, or at touch time, to gums and tongue, as long as the subject remains mechanically ventilated for the duration of hospitalization.
OTHERSterile Water moisten cotton tipped applicator
One oral care application will be performed every 4 hours, or at touch times, to gums and tongue, as long as the subject remains mechanically ventilated for the duration of hospitalization.
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
7 Days to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility | duration of study, for up to 30 months | percentage of participants with retention |
| Duration of Mechanical Ventilation | 3 days | Time on invasive mechanical ventilation will be measured in days |
Countries
United States
Participant flow
Recruitment details
Of the 82 mechanically ventilated infants ≤ 28 weeks gestation who were screened, 46 met eligibility criteria. Of these eligible infants 41(89%) were recruited and randomized.
Participants by arm
| Arm | Count |
|---|---|
| Biotene OralBalance® Gel Arm 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.
Biotene OralBalance® gel : Biotene OralBalance® gel is dispensed as 42gm, patient specific tube from hospital's Central Pharmacy. One pea-size oral application every 4 hours, or at touch time, to gums and tongue, as long as the subject remains mechanically ventilated for the duration of hospitalization. | 20 |
| Sterile Water Arm Sterile Water moisten cotton tipped applicator : One oral care application will be performed every 4 hours, or at touch times, to gums and tongue, as long as the subject remains mechanically ventilated for the duration of hospitalization. | 21 |
| Total | 41 |
Baseline characteristics
| Characteristic | Sterile Water Arm | Biotene OralBalance® Gel Arm | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 21 Participants | 20 Participants | 41 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 25 gestational age (weeks) INTER_QUARTILE_RANGE 0 | 24 gestational age (weeks) INTER_QUARTILE_RANGE 0 | 24 gestational age (weeks) INTER_QUARTILE_RANGE 0 |
| Region of Enrollment United States | 21 participants | 20 participants | 41 participants |
| Sex: Female, Male Female | 10 Participants | 13 Participants | 23 Participants |
| Sex: Female, Male Male | 11 Participants | 7 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 20 | 0 / 21 |
| serious Total, serious adverse events | 0 / 20 | 0 / 21 |
Outcome results
Primary
Duration of Mechanical Ventilation
Time on invasive mechanical ventilation will be measured in days
Time frame: 3 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Biotene OralBalance® Gel Arm | Duration of Mechanical Ventilation | 32 ventilator-days | Standard Deviation 15 |
| Sterile Water Group | Duration of Mechanical Ventilation | 30 ventilator-days | Standard Deviation 13 |
Primary
Feasibility
percentage of participants with retention
Time frame: duration of study, for up to 30 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Biotene OralBalance® Gel Arm | Feasibility | 100 percentage of participants retained |
| Sterile Water Group | Feasibility | 100 percentage of participants retained |