Actively Recruiting

Phase Not Applicable
Age: 1Hour - 3Days
All Genders
ID06000761

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

Led by University of Florida · Updated on 2025-04-01

218

Participants Needed

1

Research Sites

12 weeks

Total Duration

On this page

Sponsors

U

University of Florida

Lead Sponsor

T

The Gerber Foundation

Collaborating Sponsor

AI-Summary

What this Trial Is About

Premature very low birth weight (VLBW) infants face risks from infrequent and inconsistent oral care, which may lead to complications like oral dysbiosis. While frequent standardized oral care has shown benefits in critically ill adults, no guidelines exist for VLBW infants in neonatal intensive care units (NICUs). This research aims to study the effect of such care on reducing oral dysbiosis and improving health outcomes in these vulnerable infants. The study compares three groups receiving standardized oral care: one group will have oral care every 3-4 hours using human milk (donor or breast milk), the second group will have oral care every 3-4 hours using sterile water, and the third group will have oral care every 12 hours using sterile water. Oral care involves cleaning the oral cavity with sponge-tipped swabs saturated with human milk or sterile water and suctioning secretions as needed. This care will be provided over a 4-week period following birth. Participants will be monitored for oral microbiome dysbiosis during the first 28 days. Researchers will also track occurrences of ventilator-associated pneumonia, bronchopulmonary dysplasia, and the number of days requiring respiratory support up to 60 days. The study involves detailed oral assessments and respiratory evaluations to understand the impact of oral care frequency and method. Participation lasts for the first 4 to 8 weeks after birth, including safety monitoring and health outcome measurements.

CONDITIONS

Brief Title

Frequent Standardized Oral Care Using Human Milk in the Neonatal Intensive Care Unit

Who Can Participate

Age: 1Hour - 3Days
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Mother 18 years of age or older
  • Infant born at 30 weeks gestation or less
  • Infant born weighing 1500 grams or less
Not Eligible

You will not qualify if you...

  • Congenital anomalies of the face, lungs, or gastrointestinal system
  • Infant not expected to live longer than 7 days following delivery

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - Up to 28 days

Participants receive standardized oral care using human milk or sterile water at different frequencies to prevent oral dysbiosis and improve health outcomes.

Oral care every 3-4 hours or every 12 hours depending on group assignment

Trial Site Locations

Total: 1 location

1

Neonatal intensive care unit at Shands children's hospital at the Univeristy of Florida

Gainesville, Florida, United States, 32504

Actively Recruiting

Loading map...

Research Team

L

Leslie A Parker, PhD, APRN

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

PREVENTION

Number of Arms

3

Similar Trials

Lung Barometric Measurements in Normal And in Respiratory Di...

Ventilator-Induced Lung Injury

Actively Recruiting

1 location

A Phase 2b Study Evaluating OHB-607 Compared to Standard Neo...

Bronchopulmonary Dysplasia

Actively Recruiting

66 locations

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here