NCT05167318

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: University of Florida · Academic / Other
• Sex: All
• Age: 12 Hours – 72 Hours
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
OTHER	frequent standardized oral care	Standardized oral care will be provided every 3-4 hours

Timeline

• Start date: 2022-01-15
• Primary completion: 2023-10-02
• Completion: 2026-03-30
• First posted: 2021-12-22
• Last updated: 2025-12-11

Locations

1 site across 1 country: United States