An interventional study of Standardized oral Care in Ventilator Associated Pneumonia, Bronchopulmonary Dysplasia and Respiratory Disease, sponsored by University of Florida. Recruiting at 1 site in United States. Open to participants aged 1 Hour to 3 Days. Per ClinicalTrials.gov, last updated 2026-07-08.
Sponsored by University of Florida · Not applicable, Interventional, and Prevention
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.
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.
392 studies on the registry are indexed under Pneumonia, Ventilator-Associated; 81 are open to participants now.
This study's planned enrollment of 218 is above the median of 122 across 254 interventional studies indexed under Pneumonia, Ventilator-Associated.
Browse Pneumonia, Ventilator-Associated studies →University of Florida is the lead sponsor of 1,254 studies on the registry; 201 are open to participants now.
Of its 170 completed or terminated interventional studies of FDA-regulated products, 136 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion:
Standardized oral care performed every 3-4 hours using human milk, donor or breast milk.
Procedure: Standardized oral Care
Standardized oral care performed every 3-4 hours using sterile water.
Procedure: Standardized oral Care
Standardized oral care performed every 12 hours using sterile water.
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.
Number of participants with oral microbiome dysbiosis.
Oral samples will be obtained weekly and the microbiome analyzed using rRNA 16s sequencing
Time frame: 0-28 days
Number of participants with ventilator associated pneumonia
Evidence of ventilator pneumonia will be assessed weekly over the first 4 weeks of life
Time frame: 0-28 days
Number of participants with bronchopulmonary dysplasia
Evidence of bronchopulmonary dysplasia will be assessed weekly over the first 60 days of life
Time frame: 0-60 days
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
Time frame: 0-60 days
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Plan to share: No
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Pneumonia, Ventilator-Associated→
University of Florida