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Clinical Trials/NCT05167318
NCT05167318
Active, not recruiting
Not Applicable

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

University of Florida1 site in 1 country150 target enrollmentJanuary 15, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Microbial Colonization
Sponsor
University of Florida
Enrollment
150
Locations
1
Primary Endpoint
Type of of bacterial in the oral cavity
Status
Active, not recruiting
Last Updated
4 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 15, 2022
End Date
March 30, 2026
Last Updated
4 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Type of of bacterial in the oral cavity

Time Frame: weekly for 4 weeks

microbial analysis of the oral microbiome

Secondary Outcomes

  • Incidence of chronic lung disease(Up to 100 days)
  • Days of respiratory support(Up to 100 days)

Study Sites (1)

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