Actively Recruiting
Frequent Standardized Oral Care Using Human Milk to Prevent Oral Dysbiosis and Improve Health Outcomes in Premature Infants in the Neonatal Intensive Care Unit
Led by University of Florida · Updated on 2025-04-01
218
Participants Needed
1
Research Sites
12 weeks
Total Duration
On this page
Sponsors
U
University of Florida
Lead Sponsor
T
The Gerber Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
Premature very low birth weight (VLBW) infants face risks from infrequent and inconsistent oral care, which may lead to complications like oral dysbiosis. While frequent standardized oral care has shown benefits in critically ill adults, no guidelines exist for VLBW infants in neonatal intensive care units (NICUs). This research aims to study the effect of such care on reducing oral dysbiosis and improving health outcomes in these vulnerable infants. The study compares three groups receiving standardized oral care: one group will have oral care every 3-4 hours using human milk (donor or breast milk), the second group will have oral care every 3-4 hours using sterile water, and the third group will have oral care every 12 hours using sterile water. Oral care involves cleaning the oral cavity with sponge-tipped swabs saturated with human milk or sterile water and suctioning secretions as needed. This care will be provided over a 4-week period following birth. Participants will be monitored for oral microbiome dysbiosis during the first 28 days. Researchers will also track occurrences of ventilator-associated pneumonia, bronchopulmonary dysplasia, and the number of days requiring respiratory support up to 60 days. The study involves detailed oral assessments and respiratory evaluations to understand the impact of oral care frequency and method. Participation lasts for the first 4 to 8 weeks after birth, including safety monitoring and health outcome measurements.
CONDITIONS
Brief Title
Frequent Standardized Oral Care Using Human Milk in the Neonatal Intensive Care Unit
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Mother 18 years of age or older
- Infant born at 30 weeks gestation or less
- Infant born weighing 1500 grams or less
You will not qualify if you...
- Congenital anomalies of the face, lungs, or gastrointestinal system
- Infant not expected to live longer than 7 days following delivery
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 28 days
Participants receive standardized oral care using human milk or sterile water at different frequencies to prevent oral dysbiosis and improve health outcomes.
Oral care every 3-4 hours or every 12 hours depending on group assignment
Trial Site Locations
Total: 1 location
1
Neonatal intensive care unit at Shands children's hospital at the Univeristy of Florida
Gainesville, Florida, United States, 32504
Actively Recruiting
Research Team
L
Leslie A Parker, PhD, APRN
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
PREVENTION
Number of Arms
3
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