Trial Outcomes & Findings for Study of Biotene OralBalance Gel for Oral Care in Critically-Ill Mechanically Ventilated Neonates (NCT NCT01314742)
NCT ID: NCT01314742
Last Updated: 2018-09-11
Results Overview
percentage of participants with retention
Recruitment status
COMPLETED
Study phase
EARLY_PHASE1
Target enrollment
41 participants
Primary outcome timeframe
duration of study, for up to 30 months
Results posted on
2018-09-11
Participant Flow
Of the 82 mechanically ventilated infants ≤ 28 weeks gestation who were screened, 46 met eligibility criteria. Of these eligible infants 41(89%) were recruited and randomized.
Participant milestones
| Measure |
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.
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.
|
Sterile Water Arm
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.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
21
|
|
Overall Study
COMPLETED
|
20
|
21
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Biotene OralBalance Gel for Oral Care in Critically-Ill Mechanically Ventilated Neonates
Baseline characteristics by cohort
| Measure |
Biotene OralBalance® Gel Arm
n=20 Participants
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.
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.
|
Sterile Water Arm
n=21 Participants
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.
|
Total
n=41 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
20 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
41 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
24 gestational age (weeks)
INTER_QUARTILE_RANGE 0 • n=99 Participants
|
25 gestational age (weeks)
INTER_QUARTILE_RANGE 0 • n=107 Participants
|
24 gestational age (weeks)
INTER_QUARTILE_RANGE 0 • n=206 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=99 Participants
|
21 participants
n=107 Participants
|
41 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: duration of study, for up to 30 monthspercentage of participants with retention
Outcome measures
| Measure |
Biotene OralBalance® Gel Arm
n=20 Participants
Study group receiving timed oral care with Biotene OralBalance® gel Arm
|
Sterile Water Group
n=21 Participants
Study group receiving timed oral care with Sterile Water
|
|---|---|---|
|
Feasibility
|
100 percentage of participants retained
|
100 percentage of participants retained
|
PRIMARY outcome
Timeframe: 3 daysTime on invasive mechanical ventilation will be measured in days
Outcome measures
| Measure |
Biotene OralBalance® Gel Arm
n=20 Participants
Study group receiving timed oral care with Biotene OralBalance® gel Arm
|
Sterile Water Group
n=21 Participants
Study group receiving timed oral care with Sterile Water
|
|---|---|---|
|
Duration of Mechanical Ventilation
|
32 ventilator-days
Standard Deviation 15
|
30 ventilator-days
Standard Deviation 13
|
Adverse Events
Biotene OralBalance® Gel Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sterile Water Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Beatrice Stefanescu
Vanderbilt University Sch of Medicine
Phone: 6159365933
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place