Ventilator-associated PneumoniaEarly Phase 1NCT01314742
Study of Biotene OralBalance Gel for Oral Care in Critically-Ill Mechanically Ventilated Neonates
A Early Phase 1 study testing Biotene OralBalance® gel and Sterile Water moisten cotton tipped applicator in people with Ventilator-associated Pneumonia, run by Wake Forest University Health Sciences at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 7 days and older
- Conditions the study is for
- Ventilator-associated Pneumonia
- What is being tested?
- Biotene OralBalance® gel and Sterile Water moisten cotton tipped applicator
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2010to Jul 2012
- Phase
- Early Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 days and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Neonates who are mechanically ventilated between 7 and 10 days old. Signed parental informed consent is required for recruitment into the study.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Forsyth Medical Center
Winston-Salem, North Carolina, 27103
Brenner Children's Hospital
Winston-Salem, North Carolina, 27157
About this study
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
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.
Read the 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.
- Conditions
- Ventilator-associated Pneumonia
- Being tested
- Biotene OralBalance® gel, Sterile Water moisten cotton tipped applicator
- Keywords
- neonates, mechanical ventilation, oral care, duration of mechanical ventilation, feasibility, ventilator-associated pneumonia
- Medical subject headings
- Pneumonia, Ventilator-Associated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biotene OralBalance® gelDrug
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.
Sterile Water moisten cotton tipped applicatorOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Biotene OralBalance® gel |
| Sterile Water Arm | Placebo comparator | Sterile Water moisten cotton tipped applicator Receives: Other: Sterile Water moisten cotton tipped applicator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility
percentage of participants with retention
Measured: duration of study, for up to 30 months
Duration of Mechanical Ventilation
Time on invasive mechanical ventilation will be measured in days
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2011 (estimated)
- Study startMay 2010
- Primary completionJan 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Ventilator-associated PneumoniaStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Beatrice Stefanescu, MD, MS, Principal investigator, Wake Forest University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01314742
- Sponsor's protocol ID
- IRB00013036
- Other IDs
- FMC 2010-100
- Status last verified
- Aug 2018
- First submitted
- 9 Mar 2011
- Last updated
- 11 Sep 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 11936452Tenovuo 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.
PubMed 1896432Epstein 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.
PubMed 10435146Apisarnthanarak 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.
PubMed 14654598Chlebicki 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.
PubMed 17205028Stefanescu 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.
PubMed 23608625
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01314742
- Acronym / sponsor ID
- IRB00013036
- Conditions
- Ventilator-associated Pneumonia
- Keywords
- neonates, mechanical ventilation, oral care, duration of mechanical ventilation, feasibility, ventilator-associated pneumonia
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 14 Mar 2011 (estimated)
- Results
- Posted 4 Feb 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Biotene OralBalance® gel Arm | Experimental | Drug: Biotene OralBalance® gelBiotene 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. |
| Sterile Water Arm | Placebo comparator | Other: Sterile Water moisten cotton tipped applicatorSterile Water moisten cotton tipped applicator |
Who may qualify
- Ages
- 7 days and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Neonates who are mechanically ventilated between 7 and 10 days old. Signed parental informed consent is required for recruitment into the study.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biotene OralBalance® gelBiotene 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. | Drug | Biotene OralBalance® gel Arm |
| Sterile Water moisten cotton tipped applicatorOne 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. | Other | Sterile Water Arm |
Primary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 11936452Tenovuo 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.
- Background: PubMed 1896432Tenovuo 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.
- Background: PubMed 10435146Epstein 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.
- Background: PubMed 14654598Apisarnthanarak 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.
- Background: PubMed 17205028Chlebicki 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.
- Results publication: PubMed 23608625Stefanescu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Beatrice Stefanescu, MD, MS principal investigator
Wake Forest University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Biotene OralBalance® gel and Sterile Water moisten cotton tipped applicator in people with Ventilator-associated Pneumonia, run by Wake Forest University Health Sciences at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Feb 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility (time frame: duration of study, for up to 30 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01314742, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2018.