NCT05167318

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

Active, enrolled NA Last updated 11 December 2025

What this trial tests

NA trial testing frequent standardized oral care in Microbial Colonization in 150 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

15 January 2022

Primary endpoint
2 October 2023

30 March 2026

Quick facts

Lead sponsor	University of Florida
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	150
Start date	15 January 2022
Primary completion	2 October 2023
Estimated completion	30 March 2026
Sites	1 location across United States

Drugs / interventions tested

• frequent standardized oral care

Conditions studied

• Microbial Colonization — all drugs for Microbial Colonization →
• Ventilator Associated Pneumonia — all drugs for Ventilator Associated Pneumonia →

Sponsor

University of Florida

Who can join

Adults 12 Hours to 72 Hours, any sex, with Microbial Colonization or Ventilator Associated Pneumonia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own 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 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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.