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NCT05167318 · ClinicalTrials.gov registry record · NA
Frequent Standardized Oral Care to Improve Health Outcomes in Premature Infants in the Neonatal Intensive Care Unit
A NA study of Microbial Colonization and Ventilator Associated Pneumonia, sponsored by University of Florida.
- Active
- Registry status
- NA
- Development phase
- 150
- Enrollment target
- 1
- Study location
NCT05167318: Active NA study of Microbial Colonization and Ventilator Associated Pneumonia, sponsored by University of Florida.
NCT05167318 is a NA study of Microbial Colonization and Ventilator Associated Pneumonia that is active but no longer recruiting, run by University of Florida. The registered enrollment target is 150 participants, below the 12,647-participant average among 20 other Microbial Colonization trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05167318, a NA study of Microbial Colonization and Ventilator Associated Pneumonia, is active but no longer recruiting, sponsored by University of Florida.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 150 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
microbial analysis of the oral microbiome
Conditions Studied
Interventions
- OTHER frequent standardized oral care
Study Locations (1)
Florida
- University of Florida - Gainesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2022-01-15 |
| Est. Completion | 2026-03-30 |
| Phase | NA |
What the registry record for NCT05167318 still lists
NCT05167318 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, below the 12,647-participant average among 20 other Microbial Colonization trials with a reported enrollment target (99% lower).
The record links to 2 conditions, with Microbial Colonization appearing as the primary indexed condition, and to 1 intervention - of which frequent standardized oral care is the first listed.
NCT05167318 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT05167318 about?
NCT05167318 is a clinical study titled "Frequent Standardized Oral Care to Improve Health Outcomes in Premature Infants in the Neonatal Intensive Care Unit". 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 com...
What is the current status of trial NCT05167318?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 150 participants. The study started on 2022-01-15. Estimated completion is 2026-03-30.
What conditions does trial NCT05167318 study?
This clinical trial studies the following conditions: Microbial Colonization, Ventilator Associated Pneumonia.
What interventions are being tested in trial NCT05167318?
The interventions under investigation include: frequent standardized oral care (OTHER).
Who is sponsoring clinical trial NCT05167318?
This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05167318 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05167318's enrollment target sits among peer trials
150 8th of 20 higher than 12 of 20 other Microbial Colonization trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Microbial Colonization trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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