NCT06000761 · University of Florida
Frequent Standardized Oral Care Using Human Milk in the Neonatal Intensive Care Unit
What this study is about
Premature infants are susceptible to complications related to infrequent and non-standardized taken by mouth care.
View original scientific description
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.
Interventions
PROCEDURE
Standardized oral Care
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 measures
Number of participants with oral microbiome dysbiosis.
Time frame: 0-28 days
Oral samples will be obtained weekly and the microbiome analyzed using rRNA 16s sequencing
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Mother ≥18 years of age
- ≤ 30 weeks gestation
- Born weighing ≤ 1500 grams
Exclusion criteria
- Congenital anomalies of the face, lungs, or gastrointestinal system
- Not expected to live \> 7 days following delivery.
Where
- Gainesville, Florida
Collaborators
The Gerber Foundation
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
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Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
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Data: ClinicalTrials.gov · synced Jul 8, 2026 · Source of record for eligibility and locations