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

NCT06000761 | Recruiting

• 1 other identifier: 202101340
• Study Type: interventional
• Target: 218
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Number of participants with oral microbiome dysbiosis.

  Oral samples will be obtained weekly and the microbiome analyzed using rRNA 16s sequencing

  0-28 days

Secondary Outcomes (3)

• Number of participants with ventilator associated pneumonia

  0-28 days

• Number of participants with bronchopulmonary dysplasia

  0-60 days

• Number of days requiring respiratory support

  0-60 days

Study Arms (3)

Group 1

ACTIVE COMPARATOR

Standardized oral care performed every 3-4 hours using human milk, donor or breast milk.

Procedure: Standardized oral Care

Group 2

ACTIVE COMPARATOR

Standardized oral care performed every 3-4 hours using sterile water.

Procedure: Standardized oral Care

Group 3

ACTIVE COMPARATOR

Standardized oral care performed every 12 hours using sterile water.

Procedure: Standardized oral Care

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.

Group 1; Group 2; Group 3

Eligibility Criteria

• Age: 1 Hour - 3 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Mother ≥18 years of age
• ≤ 30 weeks gestation
• Born weighing ≤ 1500 grams

You may not qualify if:

• Congenital anomalies of the face, lungs, or gastrointestinal system
• Not expected to live \> 7 days following delivery.

Sponsors & Collaborators

• University of Florida: lead
• The Gerber Foundation: collaborator

Study Sites (1)

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

Gainesville, Florida, 32504, United States

RECRUITING

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated; Bronchopulmonary Dysplasia; Respiration Disorders

Condition Hierarchy (Ancestors)

Healthcare-Associated Pneumonia; Cross Infection; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ventilator-Induced Lung Injury; Lung Injury; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Leslie Parker, PHD

  University of Florida

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Leslie A Parker, PhD, APRN

CONTACT

352-273-6384; parkela@ufl.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: All de-identified saliva and breast milk samples will be conducted at a UF lab outside of Shands. ETT culture samples will also be de-identified before sending to Shands CoreLab. Investigators determining clinical outcomes will be blinded to group allocation
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The proposed study will prospectively follow 168 VLBW infants and 168 mothers (dyad) for 4 weeks following birth. Infants will be randomized into 1 of 3 groups. Standardized oral care will be performed every 3-4 hours using human milk (Group 1), every 3-4 hours using sterile water (Group 2) or every 12 hours using sterile water (Group 3).

Study Record Dates

• First Submitted: August 14, 2023
• First Posted: August 21, 2023
• Study Start: November 23, 2023
• Primary Completion (Estimated): September 23, 2026
• Study Completion (Estimated): December 20, 2026
• Last Updated: April 1, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)