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

Study Overview
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Brief Summary
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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.

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

Conditions
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Microbial Colonization, Ventilator Associated Pneumonia

Intervention / Treatment
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* Other: frequent standardized oral care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Hours
Maximum Age: 72 Hours

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: every 3-4 hour oral care<br>Infants will receive standardized oral care every 3-4 hours for 4 weeks | Other: frequent standardized oral care<br>* Standardized oral care will be provided every 3-4 hours<br>|
| No Intervention: every 12 hour oral care<br>Infants will receive standardized oral care every 12 hours for 4 weeks | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Type of of bacterial in the oral cavity | microbial analysis of the oral microbiome | weekly for 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Days of respiratory support | number of days infant was on respiratory support | Up to 100 days | 
| Incidence of chronic lung disease | Whether or not the infant was diagnosed with chronic lung disease | Up to 100 days |