Frequent Standardized Oral Care in the Neonatal Intensive Care Unit
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Group 1 Standardized oral care performed every 3-4 hours using human milk, donor or breast milk. |
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.
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| Active Comparator: Group 2 Standardized oral care performed every 3-4 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.
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| Active Comparator: Group 3 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.
|
Outcome Measures
Primary Outcome Measures
- Determine the effect of standardized frequent oral care using human milk on the oral microbiome including bacterial pathogenicity determinants in premature VLBW infants. [weekly x 4]
A sample of the infant's saliva will be collected weekly for 4 weeks by the research coordinator (a registered nurse experienced in the care of critically ill infants) by gently inserting a sterile brush into the infant's mouth and gently rotating the swab.
Secondary Outcome Measures
- Compare respiratory outcomes including evidence of ventilator associated pneumonia (VAP) (positive ETT culture, incidence of ventilator associated events), days on invasive and non-invasive respiratory support, and incidence of BPD between groups. [Daily for 4 weeks]
Diagnosis of ventilator associated pneumonia and/or bronchopulmonary, days of respiratory support
Eligibility Criteria
Criteria
Inclusion Criteria:
Mothers who are > 18 years of age, 2) infant(s), including multiples, born at < 30 weeks, 3) infant with birth weight at < 1500 grams
Exclusion Criteria:
Infants with born congenital anomalies of the face, lungs, or gastrointestinal system 2) infant not expected to live > 7 days following delivery.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Neonatal intensive care unit at Shands children's hospital at the Univeristy of Florida | Gainesville | Florida | United States | 32504 |
Sponsors and Collaborators
- University of Florida
- The Gerber Foundation
Investigators
- Principal Investigator: Leslie Parker, PHD, University of Florida
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 202101340