+1 877 705 1914• 24 / 7
HIPAA Compliant
ISO 27001 Certified

Actively Recruiting

Phase Not Applicable
Age: 1Hour - 3Days
All Genders
ID06000761

Oral Care Using Human Milk to Prevent Complications in Very Low Birth Weight Premature Infants in the NICU

Led by University of Florida · Updated on 2026-07-08

218

Participants Needed

1

Research Sites

12 weeks

Total Duration

AI-Summary

What this Trial Is About

Premature very low birth weight VLBW infants are at risk for complications due to infrequent and non-standardized oral care. While frequent standardized oral care is known to reduce harmful bacteria and complications in critically ill adults, similar data and guidelines for VLBW infants in neonatal intensive care units NICUs do not exist. This study aims to investigate the effects of frequent standardized oral care on reducing oral dysbiosis and improving health outcomes in these vulnerable infants. The study compares three oral care approaches standardized oral care every 3-4 hours using human milk donor or breast milk, every 3-4 hours using sterile water, and every 12 hours using sterile water. Oral care involves cleaning the oral cavity with sponge-tipped swabs saturated with the assigned solution, cleaning lips with sterile gauze, and suctioning secretions as needed. The study will prospectively follow 168 VLBW infants for 4 weeks after birth under a randomized, single-masked design. Participants will be monitored for oral microbiome dysbiosis during the first 28 days and for complications such as ventilator-associated pneumonia, bronchopulmonary dysplasia, and days requiring respiratory support up to 60 days. Assessments include clinical monitoring, oral care procedures, and health outcome measurements. The research seeks to develop evidence-based oral care guidelines to potentially improve health and reduce costly complications for premature infants in NICUs.

CONDITIONS

Brief Title

Frequent Standardized Oral Care Using Human Milk in the Neonatal Intensive Care Unit

Research Team

L

Leslie A Parker, PhD, APRN

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here