Frequent Standardized Oral Care Using Human Milk to Prevent Oral Dysbiosis and Improve Health Outcomes in Premature Infants in the Neonatal Intensive Care Unit
Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: Newborn
Maximum Age: 3 days
Healthy Volunteers: f
View:
• Mother ≥18 years of age
• ≤ 30 weeks gestation
• Born weighing ≤ 1500 grams
Locations
United States
Florida
Neonatal intensive care unit at Shands children's hospital at the Univeristy of Florida
RECRUITING
Gainesville
Contact Information
Primary
Leslie A Parker, PhD, APRN
parkela@ufl.edu
352-273-6384
Time Frame
Start Date: 2023-11-23
Estimated Completion Date: 2026-12-20
Participants
Target number of participants: 218
Treatments
Active_comparator: Group 1
Standardized oral care performed every 3-4 hours using human milk, donor or breast milk.
Active_comparator: Group 2
Standardized oral care performed every 3-4 hours using sterile water.
Active_comparator: Group 3
Standardized oral care performed every 12 hours using sterile water.
Related Therapeutic Areas
Sponsors
Leads: University of Florida
Collaborators: The Gerber Foundation