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

Microbial Colonization Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05167318
• Other study ID #: IRB202101340
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 15, 2022
• Est. completion date: October 2, 2025

Study information

• Verified date: November 2023
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 150
• Est. completion date: October 2, 2025
• Est. primary completion date: October 2, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Hours to 72 Hours

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Microbial Colonization
• Pneumonia, Ventilator-Associated
• Ventilator Associated Pneumonia

Intervention

Other:
• frequent standardized oral care
Standardized oral care will be provided every 3-4 hours

Locations

Country	Name	City	State
United States	University of Florida	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Type of of bacterial in the oral cavity	microbial analysis of the oral microbiome	weekly for 4 weeks
Secondary	Days of respiratory support	number of days infant was on respiratory support	Up to 100 days
Secondary	Incidence of chronic lung disease	Whether or not the infant was diagnosed with chronic lung disease	Up to 100 days