Frequent Standardized Oral Care Using Human Milk in the Neonatal Intensive Care Unit
Primary Purpose
Ventilator Associated Pneumonia, Bronchopulmonary Dysplasia, Respiratory Disease
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Standardized oral Care
Sponsored by
About this trial
This is an interventional prevention trial for Ventilator Associated Pneumonia
Eligibility Criteria
Inclusion: Mother ≥18 years of age ≤ 30 weeks gestation Born weighing ≤ 1500 grams Exclusion: Congenital anomalies of the face, lungs, or gastrointestinal system Not expected to live > 7 days following delivery.
Sites / Locations
- Neonatal intensive care unit at Shands children's hospital at the Univeristy of Florida
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Group 1
Group 2
Group 3
Arm Description
Standardized oral care performed every 3-4 hours using human milk, donor or breast milk.
Standardized oral care performed every 3-4 hours using sterile water.
Standardized oral care performed every 12 hours using sterile water.
Outcomes
Primary Outcome Measures
Number of participants with oral microbiome dysbiosis.
Oral samples will be obtained weekly and the microbiome analyzed using rRNA 16s sequencing
Secondary Outcome Measures
Number of participants with ventilator associated pneumonia
Evidence of ventilator pneumonia will be assessed weekly over the first 4 weeks of life
Number of participants with bronchopulmonary dysplasia
Evidence of bronchopulmonary dysplasia will be assessed weekly over the first 60 days of life
Number of days requiring respiratory support
Days the infant was on any type of respiratory support will be assessed daily for the first 60 days of life
Full Information
NCT ID
NCT06000761
First Posted
August 14, 2023
Last Updated
September 5, 2023
Sponsor
University of Florida
Collaborators
The Gerber Foundation
1. Study Identification
Unique Protocol Identification Number
NCT06000761
Brief Title
Frequent Standardized Oral Care Using Human Milk in the Neonatal Intensive Care Unit
Official Title
Frequent Standardized Oral Care Using Human Milk to Prevent Oral Dysbiosis and Improve Health Outcomes in Premature Infants in the Neonatal Intensive Care Unit
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 23, 2023 (Anticipated)
Primary Completion Date
September 23, 2026 (Anticipated)
Study Completion Date
December 20, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
Collaborators
The Gerber Foundation
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 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 dysbiosis (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 168 VLBW infants for 4 weeks following birth.
Detailed Description
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 dysbiosis (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. Premature VLBW infants are highly susceptible to costly, life threatening and potentially preventable morbidities, such as ventilator associated pneumonia (VAP), bronchopulmonary dysplasia (BPD; oxygen requirement at 28 days of life) and need for prolonged respiratory support which require additional treatments, increase cost of care, and can lead to chronic illness, re-hospitalization, and developmental delay. A dearth of information exists regarding oral care in VLBW infants, and no such guidelines exist for infants admitted to the neonatal intensive care unit (NICU) which may negatively affect their health. Thus, research regarding the effect of frequent, standardized oral care on the health of VLBW infants is essential to develop guidelines thus potentially improving the health of this vulnerable population. If successful, this research could change practice in NICUs across the nation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventilator Associated Pneumonia, Bronchopulmonary Dysplasia, Respiratory Disease
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
The proposed study will prospectively follow 168 VLBW infants and 168 mothers (dyad) for 4 weeks following birth. Infants will be randomized into 1 of 3 groups. Standardized oral care will be performed every 3-4 hours using human milk (Group 1), every 3-4 hours using sterile water (Group 2) or every 12 hours using sterile water (Group 3).
Masking
Outcomes Assessor
Masking Description
All de-identified saliva and breast milk samples will be conducted at a UF lab outside of Shands. ETT culture samples will also be de-identified before sending to Shands CoreLab. Investigators determining clinical outcomes will be blinded to group allocation
Allocation
Randomized
Enrollment
218 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Active Comparator
Arm Description
Standardized oral care performed every 3-4 hours using human milk, donor or breast milk.
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
Standardized oral care performed every 3-4 hours using sterile water.
Arm Title
Group 3
Arm Type
Active Comparator
Arm Description
Standardized oral care performed every 12 hours using sterile water.
Intervention Type
Procedure
Intervention Name(s)
Standardized oral Care
Intervention Description
One sponge-tipped swab, saturated with sterile water or human milk, will used clean the oral cavity with 15 seconds each area. Surfaces include all 4 quadrants of the gum surface and upper posterior part of the oropharynx. A second swab, with sterile water or milk will be used on the ventral and posterior surfaces of the tongue. A third swab, saturated with sterile water or human milk, will be used to clean the outer surface of any dwelling oral tubes (endotracheal tube, NAVA or feeding tube). Lips will be cleaned with a sterile gauze saturated with sterile water or human milk. Oral cavity will be suctioned as needed with an oral suction devise to remove secretions.
Primary Outcome Measure Information:
Title
Number of participants with oral microbiome dysbiosis.
Description
Oral samples will be obtained weekly and the microbiome analyzed using rRNA 16s sequencing
Time Frame
0-28 days
Secondary Outcome Measure Information:
Title
Number of participants with ventilator associated pneumonia
Description
Evidence of ventilator pneumonia will be assessed weekly over the first 4 weeks of life
Time Frame
0-28 days
Title
Number of participants with bronchopulmonary dysplasia
Description
Evidence of bronchopulmonary dysplasia will be assessed weekly over the first 60 days of life
Time Frame
0-60 days
Title
Number of days requiring respiratory support
Description
Days the infant was on any type of respiratory support will be assessed daily for the first 60 days of life
Time Frame
0-60 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Hour
Maximum Age & Unit of Time
3 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion:
Mother ≥18 years of age
≤ 30 weeks gestation
Born weighing ≤ 1500 grams
Exclusion:
Congenital anomalies of the face, lungs, or gastrointestinal system
Not expected to live > 7 days following delivery.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Leslie A Parker, PhD, APRN
Phone
352-273-6384
Email
parkela@ufl.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leslie Parker, PHD
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
Neonatal intensive care unit at Shands children's hospital at the Univeristy of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32504
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Frequent Standardized Oral Care Using Human Milk in the Neonatal Intensive Care Unit
We'll reach out to this number within 24 hrs