Back to resultsFrequent Standardized Oral Care to Improve Health Outcomes in Premature Infants in the Neonatal Intensive Care Unit
Primary Purpose
Microbial Colonization, Ventilator Associated Pneumonia
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
frequent standardized oral care
Sponsored by
About this trial
This is an interventional prevention trial for Microbial Colonization
Eligibility Criteria
Inclusion Criteria:
- Gestational age < 32 weeks
- birth weight < 1500 grams
- mother is English speaking
- mother is > 18 years of age.
Exclusion Criteria:
- Congenital anomalies of the face, lungs, or gastrointestinal system
- not expected to survive
Sites / Locations
- University of FloridaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
every 3-4 hour oral care
every 12 hour oral care
Arm Description
Infants will receive standardized oral care every 3-4 hours for 4 weeks
Infants will receive standardized oral care every 12 hours for 4 weeks
Outcomes
Primary Outcome Measures
Type of of bacterial in the oral cavity
microbial analysis of the oral microbiome
Secondary Outcome Measures
Days of respiratory support
number of days infant was on respiratory support
Incidence of chronic lung disease
Whether or not the infant was diagnosed with chronic lung disease
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05167318
Brief Title
Frequent Standardized Oral Care to Improve Health Outcomes in Premature Infants in the Neonatal Intensive Care Unit
Official Title
Frequent Standardized Oral Care to Improve Health Outcomes in Premature Infants in the Neonatal Intensive Care Unit
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 15, 2022 (Actual)
Primary Completion Date
October 2, 2023 (Anticipated)
Study Completion Date
October 2, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Premature very low birth weight (VLBW) infants are susceptible to complications related to infrequent and non-standardized oral care. Although the benefits of frequent standardized oral care are known to reduce oral dybiosis (increased level of potentially pathogenic bacteria) and its associated complications in critically ill adults leading to established evidence-based guidelines, no such information exists for VLBW infants. The proposed study will prospectively follow 40 VLBW infants for 4 weeks following birth. Infants will be randomized into 1 of 2 groups. Standardized oral care will be performed every 3-4 hours (Group 1) and every 12 hours (Group 2). Aim 1 will evaluate the feasibility of frequent standardized oral care, Aim 2 will compare the oral microbiome between groups, and Aim 3 will compare respiratory outcomes including the incidence of ventilator associated pneumonia, bronchopulmonary dysplasia and need for respiratory support between infants receiving standardized oral care every 3-4 hours and every 12 hours. Issues related to recruitment, retention, randomization, acceptance by nursing staff, and treatment fidelity will be examined. Saliva samples will be obtained weekly and analyzed using 16S sequencing, respiratory cultures will be obtained weekly on ventilated infants, and respiratory outcomes will be collected from the medical records.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Microbial Colonization, Ventilator Associated Pneumonia
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
every 3-4 hour oral care
Arm Type
Experimental
Arm Description
Infants will receive standardized oral care every 3-4 hours for 4 weeks
Arm Title
every 12 hour oral care
Arm Type
No Intervention
Arm Description
Infants will receive standardized oral care every 12 hours for 4 weeks
Intervention Type
Other
Intervention Name(s)
frequent standardized oral care
Intervention Description
Standardized oral care will be provided every 3-4 hours
Primary Outcome Measure Information:
Title
Type of of bacterial in the oral cavity
Description
microbial analysis of the oral microbiome
Time Frame
weekly for 4 weeks
Secondary Outcome Measure Information:
Title
Days of respiratory support
Description
number of days infant was on respiratory support
Time Frame
Up to 100 days
Title
Incidence of chronic lung disease
Description
Whether or not the infant was diagnosed with chronic lung disease
Time Frame
Up to 100 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Hours
Maximum Age & Unit of Time
72 Hours
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Gestational age < 32 weeks
birth weight < 1500 grams
mother is English speaking
mother is > 18 years of age.
Exclusion Criteria:
Congenital anomalies of the face, lungs, or gastrointestinal system
not expected to survive
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leslie Parker
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leslie A Parker, PhD
Phone
352-215-9360
Email
Parkela@ufl.edu
First Name & Middle Initial & Last Name & Degree
Leslie Parker
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Frequent Standardized Oral Care to Improve Health Outcomes in Premature Infants in the Neonatal Intensive Care Unit
We'll reach out to this number within 24 hrs