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

Part of paid clinical trials in Gainesville, Florida.

Sponsor
University of Florida
Study ID
NCT06000761
Status
Recruiting
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Conditions

  • Bronchopulmonary Dysplasia
  • Respiratory Disease
  • Ventilator Associated Pneumonia

Eligibility Criteria

Sex
ALL
Age
1 Hour - 3 Days
Healthy Volunteers
Not accepted

Interventions

  • Standardized oral Care — PROCEDURE
    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.

Study Details

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.

Key Dates

Start date
Nov 23, 2023
Status verified
Mar 2025
Primary completion
Sep 23, 2026
Completion
Dec 20, 2026

Study Design

Enrollment
218 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION

Arms

  • Active Comparator: Group 1
    Standardized oral care performed every 3-4 hours using human milk, donor or breast milk.
  • Active Comparator: Group 2
    Standardized oral care performed every 3-4 hours using sterile water.
  • Active Comparator: Group 3
    Standardized oral care performed every 12 hours using sterile water.

Primary Outcome Measure

Number of participants with oral microbiome dysbiosis. [ Time Frame: 0-28 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Neonatal intensive care unit at Shands children's hospital at the Univeristy of FloridaGainesvilleFlorida32504
Leslie A Parker, PhD
[email protected]
352-215-9360
Leslie A Parker, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
Neonatal intensive care unit at Shands children's hospital at the Univeristy of Florida· Gainesville, FL

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