Frequent Standardized Oral Care to Improve Health Outcomes in Premature Infants in the Neonatal Intensive Care Unit

  • End date
    Feb 2, 2023
  • participants needed
  • sponsor
    University of Florida
Updated on 28 April 2022
ventilator associated pneumonia


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 dybiosis (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 40 VLBW infants for 4 weeks following birth. Infants will be randomized into 1 of 2 groups. Standardized oral care will be performed every 3-4 hours (Group 1) and every 12 hours (Group 2). Aim 1 will evaluate the feasibility of frequent standardized oral care, Aim 2 will compare the oral microbiome between groups, and Aim 3 will compare respiratory outcomes including the incidence of ventilator associated pneumonia, bronchopulmonary dysplasia and need for respiratory support between infants receiving standardized oral care every 3-4 hours and every 12 hours. Issues related to recruitment, retention, randomization, acceptance by nursing staff, and treatment fidelity will be examined. Saliva samples will be obtained weekly and analyzed using 16S sequencing, respiratory cultures will be obtained weekly on ventilated infants, and respiratory outcomes will be collected from the medical records.

Condition Microbial Colonization, Ventilator Associated Pneumonia
Treatment frequent standardized oral care
Clinical Study IdentifierNCT05167318
SponsorUniversity of Florida
Last Modified on28 April 2022


Yes No Not Sure

Inclusion Criteria

Gestational age < 32 weeks
birth weight < 1500 grams
mother is English speaking
mother is > 18 years of age

Exclusion Criteria

Congenital anomalies of the face, lungs, or gastrointestinal system
not expected to survive
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