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

NCT01314742 | Completed Early Phase 1 Results FDA Drug

• 2 other identifiers: IRB00013036FMC 2010-100
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 2

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.

Conditions

Ventilator-associated Pneumonia

Keywords

neonates; mechanical ventilation; oral care; duration of mechanical ventilation; feasibility; ventilator-associated pneumonia

Outcome Measures

Primary Outcomes (2)

• Feasibility

  percentage of participants with retention

  duration of study, for up to 30 months

• Duration of Mechanical Ventilation

  Time on invasive mechanical ventilation will be measured in days

  3 days

Study Arms (2)

Biotene OralBalance® gel Arm

EXPERIMENTAL

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.

Drug: Biotene OralBalance® gel

Sterile Water Arm

PLACEBO COMPARATOR

Sterile Water moisten cotton tipped applicator

Other: Sterile Water moisten cotton tipped applicator

Interventions

Biotene OralBalance® gel DRUG

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.

Biotene OralBalance® gel Arm

Sterile Water moisten cotton tipped applicator OTHER

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.

Sterile Water Arm

Eligibility Criteria

• Age: 7 Days+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Neonates who are mechanically ventilated between 7 and 10 days old. Signed parental informed consent is required for recruitment into the study.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (2)

Forsyth Medical Center

Winston-Salem, North Carolina, 27103, United States

Location

Brenner Children's Hospital

Winston-Salem, North Carolina, 27157, United States

Location

Related Publications (6)

• 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. doi: 10.1034/j.1601-0825.2002.1o781.x.

  PMID: 11936452 BACKGROUND

• 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.

  PMID: 1896432 BACKGROUND

• 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. doi: 10.1016/s1368-8375(98)00109-2.

  PMID: 10435146 BACKGROUND

• 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. doi: 10.1542/peds.112.6.1283.

  PMID: 14654598 BACKGROUND

• Chlebicki MP, Safdar N. Topical chlorhexidine for prevention of ventilator-associated pneumonia: a meta-analysis. Crit Care Med. 2007 Feb;35(2):595-602. doi: 10.1097/01.CCM.0000253395.70708.AC.

  PMID: 17205028 BACKGROUND

• Stefanescu BM, Hetu C, Slaughter JC, O'Shea TM, Shetty AK. A pilot study of Biotene OralBalance(R) 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.

  PMID: 23608625 RESULT

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated

Condition Hierarchy (Ancestors)

Healthcare-Associated Pneumonia; Cross Infection; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Beatrice Stefanescu
• Organization: Vanderbilt University Sch of Medicine

beatrice.stefanescu@Vanderbilt.edu

6159365933

Study Officials

• Beatrice Stefanescu, MD, MS

  Wake Forest University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2011
• First Posted: March 14, 2011
• Study Start: May 1, 2010
• Primary Completion: January 1, 2012
• Study Completion: July 1, 2012
• Last Updated: September 11, 2018
• Results First Posted: February 4, 2014

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)