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Clinical Trials/NCT06000761
NCT06000761
Recruiting
Not Applicable

Frequent Standardized Oral Care Using Human Milk to Prevent Oral Dysbiosis and Improve Health Outcomes in Premature Infants in the Neonatal Intensive Care Unit

University of Florida1 site in 1 country218 target enrollmentNovember 23, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Ventilator Associated Pneumonia
Sponsor
University of Florida
Enrollment
218
Locations
1
Primary Endpoint
Number of participants with oral microbiome dysbiosis.
Status
Recruiting
Last Updated
last year

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
November 23, 2023
End Date
December 20, 2026
Last Updated
last year
Study Type
Interventional
Study Design
Sequential
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Number of participants with oral microbiome dysbiosis.

Time Frame: 0-28 days

Oral samples will be obtained weekly and the microbiome analyzed using rRNA 16s sequencing

Secondary Outcomes

  • Number of days requiring respiratory support(0-60 days)
  • Number of participants with ventilator associated pneumonia(0-28 days)
  • Number of participants with bronchopulmonary dysplasia(0-60 days)

Study Sites (1)

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