Recruiting

Oral Care

Sponsor:

University of Florida

Code:

NCT06000761

Conditions

Ventilator Associated Pneumonia

Bronchopulmonary Dysplasia

Respiratory Disease

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Interventions

Standardized oral Care

Study Details

Brief summary:

Premature 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 dysbiosis (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 168 VLBW infants for 4 weeks following birth.

Conditions

Ventilator Associated Pneumonia

Bronchopulmonary Dysplasia

Respiratory Disease

Study ID

NCT06000761

Start date

Nov 23, 2023

Status verified date

Jul, 2026

Completion date

Dec 20, 2026

Anticipated

Primary completion date

Sep 23, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Inclusion:

  • Mother ≥18 years of age
  • ≤ 30 weeks gestation
  • Born weighing ≤ 1500 grams

Exclusion:

  • Congenital anomalies of the face, lungs, or gastrointestinal system
  • Not expected to live > 7 days following delivery.

Study Design

Enrollment

218 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: Group 1

Standardized oral care performed every 3-4 hours using human milk, donor or breast milk.

active comparator: Group 2

Standardized oral care performed every 3-4 hours using sterile water.

active comparator: Group 3

Standardized oral care performed every 12 hours using sterile water.

Interventions

Standardized oral Care

One sponge-tipped swab, saturated with sterile water or human milk, will used clean the oral cavity with 15 seconds each area. Surfaces include all 4 quadrants of the gum surface and upper posterior part of the oropharynx. A second swab, with sterile water or milk will be used on the ventral and posterior surfaces of the tongue. A third swab, saturated with sterile water or human milk, will be used to clean the outer surface of any dwelling oral tubes (endotracheal tube, NAVA or feeding tube). Lips will be cleaned with a sterile gauze saturated with sterile water or human milk. Oral cavity will be suctioned as needed with an oral suction devise to remove secretions.

Primary outcome measure

  • Number of participants with oral microbiome dysbiosis. [ Time Frame: 0-28 days ]

Central Contacts and Locations

Central contacts

Leslie A Parker, PhD, APRN

352-273-6384parkela@ufl.edu

Locations

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

Recruiting

Gainesville, Florida, United States, 32504

Contacts

Leslie A Parker, PhD

352-215-9360parkela@ufl.edu

Principal Investigator:

Leslie A Parker, PhD

More Information

Sponsor

University of Florida

Last update posted

Jul 8, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Florida on 2026-07-08.