Frequent Standardized Oral Care Using Human Milk in Premature Infants

This study is looking at how frequent, standardized oral care, using either sterile water or human milk, affects very low birth weight (VLBW) premature infants. Researchers want to see if this type of oral care can reduce "oral microbiome dysbiosis" (an imbalance of bacteria in the mouth) in these infants. This could potentially help prevent serious conditions like ventilator-associated pneumonia (VAP) and bronchopulmonary dysplasia (BPD). You might be able to join if you are a mother at least 18 years old, and your baby is born at 30 weeks gestation or less, weighing 1500 grams or less, and is between 1 hour and 3 days old. The study is currently recruiting 218 participants.

Study design
This is an interventional study planning to enroll 218 participants. It will follow 168 VLBW infants for 4 weeks after birth.
What's involved
Participants will receive standardized oral care using a sponge-tipped swab with either sterile water or human milk, cleaning the oral cavity for 15 seconds per area. The primary endpoint, oral microbiome dysbiosis, is measured at 0-28 days.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 4 weeks after birth, with the primary endpoint measured at 0-28 days.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06000761

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

Recruiting
NAAges 1–3InterventionalPrevention
University of Florida
~218 participants
Updated 2026-07-08 on ClinicalTrials.gov
What's tested:Standardized oral Care

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants with oral microbiome dysbiosis.
Measured over 0-28 days
Ventilator Associated Pneumonia
Bronchopulmonary Dysplasia
Respiratory Disease
1 sites across 1 states
Florida1
  • Leslie Parker, PHD · PRINCIPAL_INVESTIGATOR · University of Florida

Opens a ready-to-send draft in your own email app — review before sending.

  • Number of participants with oral microbiome dysbiosis.0-28 days

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