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

NCT01314742 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2018-09-11

Study results available
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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

Interventions

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.

Sponsors & Collaborators

  • Wake Forest University Health Sciences

    lead OTHER

Principal Investigators

  • Beatrice Stefanescu, MD, MS · Wake Forest University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
7 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2012-01-31
Completion
2012-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01314742 on ClinicalTrials.gov