Frequent Standardized Oral Care to Improve Health Outcomes in Premature Infants in the Neonatal Intensive Care Unit
Study Details
Study Description
Brief Summary
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 or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: every 3-4 hour oral care Infants will receive standardized oral care every 3-4 hours for 4 weeks |
Other: frequent standardized oral care
Standardized oral care will be provided every 3-4 hours
|
| No Intervention: every 12 hour oral care Infants will receive standardized oral care every 12 hours for 4 weeks |
Outcome Measures
Primary Outcome Measures
- Type of of bacterial in the oral cavity [weekly for 4 weeks]
microbial analysis of the oral microbiome
Secondary Outcome Measures
- Days of respiratory support [Up to 100 days]
number of days infant was on respiratory support
- Incidence of chronic lung disease [Up to 100 days]
Whether or not the infant was diagnosed with chronic lung disease
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Gestational age < 32 weeks
-
birth weight < 1500 grams
-
mother is English speaking
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mother is > 18 years of age.
Exclusion Criteria:
-
Congenital anomalies of the face, lungs, or gastrointestinal system
-
not expected to survive
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Florida | Gainesville | Florida | United States | 32610 |
Sponsors and Collaborators
- University of Florida
Investigators
- Principal Investigator: Leslie Parker, University of Florida
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IRB202101340