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

NCT05167318 | Active Not Recruiting

• 1 other identifier: IRB202101340
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Microbial Colonization; Ventilator Associated Pneumonia

Outcome Measures

Primary Outcomes (1)

• Type of of bacterial in the oral cavity

  microbial analysis of the oral microbiome

  weekly for 4 weeks

Secondary Outcomes (2)

• Days of respiratory support

  Up to 100 days

• Incidence of chronic lung disease

  Up to 100 days

Study Arms (2)

every 3-4 hour oral care

EXPERIMENTAL

Infants will receive standardized oral care every 3-4 hours for 4 weeks

Other: frequent standardized oral care

every 12 hour oral care

NO INTERVENTION

Infants will receive standardized oral care every 12 hours for 4 weeks

Interventions

frequent standardized oral care OTHER

Standardized oral care will be provided every 3-4 hours

every 3-4 hour oral care

Eligibility Criteria

• Age: 12 Hours - 72 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Gestational age \< 32 weeks
• birth weight \< 1500 grams
• mother is English speaking
• mother is \> 18 years of age.

You may not qualify if:

• Congenital anomalies of the face, lungs, or gastrointestinal system
• not expected to survive

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of Florida

Gainesville, Florida, 32610, United States

Location

MeSH Terms

Conditions

Communicable Diseases; Pneumonia, Ventilator-Associated

Condition Hierarchy (Ancestors)

Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Healthcare-Associated Pneumonia; Cross Infection; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease

Study Officials

• Leslie Parker

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2021
• First Posted: December 22, 2021
• Study Start: January 15, 2022
• Primary Completion: October 2, 2023
• Study Completion: March 30, 2026
• Last Updated: December 11, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)