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

NCT ID: NCT05167318

Last Updated: 2025-12-11

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-15
• Study Completion Date: 2026-03-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

every 3-4 hour oral care

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

Group Type: EXPERIMENTAL

frequent standardized oral care

Intervention Type: OTHER

Standardized oral care will be provided every 3-4 hours

every 12 hour oral care

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

frequent standardized oral care

Standardized oral care will be provided every 3-4 hours

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 12 Hours
• Maximum Eligible Age: 72 Hours
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Leslie Parker

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

University of Florida

Gainesville, Florida, United States

Countries

United States

Other Identifiers

IRB202101340

Identifier Type: -

Identifier Source: org_study_id