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RECRUITING
NCT06000761
NA

Frequent Standardized Oral Care Using Human Milk in the Neonatal Intensive Care Unit

Sponsor: University of Florida

View on ClinicalTrials.gov

Summary

Premature 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 dysbiosis (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 168 VLBW infants for 4 weeks following birth.

Official title: Frequent Standardized Oral Care Using Human Milk to Prevent Oral Dysbiosis and Improve Health Outcomes in Premature Infants in the Neonatal Intensive Care Unit

Key Details

Gender

All

Age Range

1 Hour - 3 Days

Study Type

INTERVENTIONAL

Enrollment

218

Start Date

2023-11-23

Completion Date

2026-12-20

Last Updated

2025-04-01

Healthy Volunteers

No

Interventions

PROCEDURE

Standardized oral Care

One sponge-tipped swab, saturated with sterile water or human milk, will used clean the oral cavity with 15 seconds each area. Surfaces include all 4 quadrants of the gum surface and upper posterior part of the oropharynx. A second swab, with sterile water or milk will be used on the ventral and posterior surfaces of the tongue. A third swab, saturated with sterile water or human milk, will be used to clean the outer surface of any dwelling oral tubes (endotracheal tube, NAVA or feeding tube). Lips will be cleaned with a sterile gauze saturated with sterile water or human milk. Oral cavity will be suctioned as needed with an oral suction devise to remove secretions.

Locations (1)

Neonatal intensive care unit at Shands children's hospital at the Univeristy of Florida

Gainesville, Florida, United States