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

Ventilator-associated Pneumonia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01314742
• Other study ID #: IRB00013036
• Secondary ID: FMC 2010-100
• Status: Completed
• Phase: Early Phase 1
• Start date: May 2010
• Est. completion date: July 2012

Study information

• Verified date: August 2018
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: July 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Pneumonia
• Pneumonia, Ventilator-Associated
• Ventilator-associated Pneumonia

Intervention

Drug:
• 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.

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.

Locations

Country	Name	City	State
United States	Brenner Children's Hospital	Winston-Salem	North Carolina
United States	Forsyth Medical Center	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

References & Publications (6)

Apisarnthanarak A, Holzmann-Pazgal G, Hamvas A, Olsen MA, Fraser VJ. Ventilator-associated pneumonia in extremely preterm neonates in a neonatal intensive care unit: characteristics, risk factors, and outcomes. Pediatrics. 2003 Dec;112(6 Pt 1):1283-9. — View Citation

Chlebicki MP, Safdar N. Topical chlorhexidine for prevention of ventilator-associated pneumonia: a meta-analysis. Crit Care Med. 2007 Feb;35(2):595-602. — View Citation

Epstein JB, Emerton S, Le ND, Stevenson-Moore P. A double-blind crossover trial of Oral Balance gel and Biotene toothpaste versus placebo in patients with xerostomia following radiation therapy. Oral Oncol. 1999 Mar;35(2):132-7. — View Citation

Stefanescu BM, Hétu C, Slaughter JC, O'Shea TM, Shetty AK. A pilot study of Biotene OralBalance® gel for oral care in mechanically ventilated preterm neonates. Contemp Clin Trials. 2013 Jul;35(2):33-9. doi: 10.1016/j.cct.2013.03.010. Epub 2013 Apr 20. — View Citation

Tenovuo J, Lumikari M, Soukka T. Salivary lysozyme, lactoferrin and peroxidases: antibacterial effects on cariogenic bacteria and clinical applications in preventive dentistry. Proc Finn Dent Soc. 1991;87(2):197-208. Review. — View Citation

Tenovuo J. Clinical applications of antimicrobial host proteins lactoperoxidase, lysozyme and lactoferrin in xerostomia: efficacy and safety. Oral Dis. 2002 Jan;8(1):23-9. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility	percentage of participants with retention	duration of study, for up to 30 months
Primary	Duration of Mechanical Ventilation	Time on invasive mechanical ventilation will be measured in days	3 days