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

Not Applicable

Active, not recruiting

• Conditions: Microbial Colonization; Ventilator Associated Pneumonia
• Interventions: Other: frequent standardized oral care

• Registration Number: NCT05167318
• Lead Sponsor: University of Florida

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-11-18
• Study First Submitted QC: 2021-12-07
• Study First Posted: 2021-12-22
• Study Start: 2022-01-15
• Primary Completion: 2023-10-02
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-18
• Last Update Posted: 2024-11-21
• Study Completion: 2025-10-02

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
every 3-4 hour oral care	frequent standardized oral care	Infants will receive standardized oral care every 3-4 hours for 4 weeks

Primary Outcome Measures

Name	Time	Method
Type of of bacterial in the oral cavity	weekly for 4 weeks	microbial analysis of the oral microbiome

Secondary Outcome Measures

Name	Time	Method
Incidence of chronic lung disease	Up to 100 days	Whether or not the infant was diagnosed with chronic lung disease
Days of respiratory support	Up to 100 days	number of days infant was on respiratory support

Trial Locations

Locations (1)

University of Florida; 🇺🇸 Gainesville, Florida, United States