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

NCT06000761 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 218

Last updated 2025-04-01

No results posted yet for this study

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.

Conditions

  • Ventilator Associated Pneumonia
  • Bronchopulmonary Dysplasia
  • Respiratory Disease

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.

Sponsors & Collaborators

  • The Gerber Foundation

    collaborator OTHER

  • University of Florida

    lead OTHER

Principal Investigators

  • Leslie Parker, PHD · University of Florida

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
SEQUENTIAL

Eligibility

Min Age
1 Hour
Max Age
3 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-23
Primary Completion
2026-09-23
Completion
2026-12-20

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06000761 on ClinicalTrials.gov