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

This study has been completed.
Information provided by (Responsible Party):
Beatrice Stefanescu, Wake Forest School of Medicine Identifier:
First received: March 9, 2011
Last updated: February 11, 2016
Last verified: February 2016
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.

Condition Intervention
Ventilator-associated Pneumonia
Other: Biotene OralBalance® gel
Other: Sterile Water moisten cotton tipped applicator

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
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

Resource links provided by NLM:

Further study details as provided by Wake Forest University Health Sciences:

Primary Outcome Measures:
  • 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

Enrollment: 41
Study Start Date: May 2010
Study Completion Date: July 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
Sponsors and Collaborators
Wake Forest University Health Sciences
Principal Investigator: Beatrice Stefanescu, MD, MS Wake Forest University
  More Information

Responsible Party: Beatrice Stefanescu, Assistant Professor of Pediatrics, Wake Forest School of Medicine Identifier: NCT01314742     History of Changes
Other Study ID Numbers: IRB00013036
FMC 2010-100 ( Other Identifier: Forsyth Medical Center IRB )
Study First Received: March 9, 2011
Results First Received: December 16, 2013
Last Updated: February 11, 2016
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Wake Forest University Health Sciences:
mechanical ventilation
oral care
duration of mechanical ventilation
ventilator-associated pneumonia

Additional relevant MeSH terms:
Pneumonia, Ventilator-Associated
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Cross Infection
Ventilator-Induced Lung Injury
Lung Injury
Anti-Infective Agents processed this record on April 28, 2017