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

May 13, 2026 updated by: University of Florida
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Gainesville, Florida, United States, 32610
        • University of Florida

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 hours to 3 days (Child)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Florida

Collaborators

National Institute of Dental and Craniofacial Research (NIDCR)

Investigators

  • Principal Investigator: Leslie Parker, University of Florida

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2022

Primary Completion (Actual)

October 2, 2023

Study Completion (Estimated)

October 30, 2026

Study Registration Dates

First Submitted

November 18, 2021

First Submitted That Met QC Criteria

December 7, 2021

First Posted (Actual)

December 22, 2021

Study Record Updates

Last Update Posted (Actual)

May 18, 2026

Last Update Submitted That Met QC Criteria

May 13, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB202101340
  • R56DE034473 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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