Study of Biotene OralBalance Gel for Oral Care in Critically-Ill Mechanically Ventilated Neonates
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|ClinicalTrials.gov Identifier: NCT01314742|
Recruitment Status : Completed
First Posted : March 14, 2011
Results First Posted : February 4, 2014
Last Update Posted : December 15, 2017
|Condition or disease||Intervention/treatment||Phase|
|Ventilator-associated Pneumonia||Other: Biotene OralBalance® gel Other: Sterile Water moisten cotton tipped applicator||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||41 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Controlled Clinical Trial of Two Different Oral Care Regimens Combined With Ventilator-Associated Pneumonia (VAP) Bundle Strategy for Reduction of Duration of Mechanical Ventilation in a Neonatal Population|
|Study Start Date :||May 2010|
|Actual Primary Completion Date :||January 2012|
|Actual Study Completion Date :||July 2012|
Experimental: 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.
Other: 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.
Placebo Comparator: Sterile Water Arm
Sterile Water moisten cotton tipped applicator
Other: 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.
- Feasibility [ Time Frame: duration of study, for up to 30 months ]percentage of participants with retention
- Duration of Mechanical Ventilation [ Time Frame: 3 days ]Time on invasive mechanical ventilation will be measured in days
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01314742
|United States, North Carolina|
|Forsyth Medical Center|
|Winston-Salem, North Carolina, United States, 27103|
|Brenner Children's Hospital|
|Winston-Salem, North Carolina, United States, 27157|
|Principal Investigator:||Beatrice Stefanescu, MD, MS||Wake Forest University|