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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Bronchopulmonary Dysplasia; Ventilator Associated Pneumonia; Respiratory Disease
• Intervention / Treatment: Procedure: Standardized oral Care

Detailed Description

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 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. Premature VLBW infants are highly susceptible to costly, life threatening and potentially preventable morbidities, such as ventilator associated pneumonia (VAP), bronchopulmonary dysplasia (BPD; oxygen requirement at 28 days of life) and need for prolonged respiratory support which require additional treatments, increase cost of care, and can lead to chronic illness, re-hospitalization, and developmental delay. A dearth of information exists regarding oral care in VLBW infants, and no such guidelines exist for infants admitted to the neonatal intensive care unit (NICU) which may negatively affect their health. Thus, research regarding the effect of frequent, standardized oral care on the health of VLBW infants is essential to develop guidelines thus potentially improving the health of this vulnerable population. If successful, this research could change practice in NICUs across the nation.

• Study Type: Interventional
• Enrollment (Estimated): 218
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Leslie A Parker, PhD, APRN; Phone Number: 352-273-6384; Email: parkela@ufl.edu

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32504
      • Recruiting
      • Neonatal intensive care unit at Shands children's hospital at the Univeristy of Florida
      • Contact: Leslie A Parker, PhD; Phone Number: 352-215-9360; Email: parkela@ufl.edu
      • Principal Investigator: Leslie A Parker, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion:

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

Exclusion:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group 1; Standardized oral care performed every 3-4 hours using human milk, donor or breast milk.	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.
Active Comparator: Group 2; Standardized oral care performed every 3-4 hours using sterile water.	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.
Active Comparator: Group 3; Standardized oral care performed every 12 hours using sterile water.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with ventilator associated pneumonia	Evidence of ventilator pneumonia will be assessed weekly over the first 4 weeks of life	0-28 days
Number of participants with bronchopulmonary dysplasia	Evidence of bronchopulmonary dysplasia will be assessed weekly over the first 60 days of life	0-60 days
Number of days requiring respiratory support	Days the infant was on any type of respiratory support will be assessed daily for the first 60 days of life	0-60 days

Collaborators and Investigators

• Sponsor: University of Florida
• Collaborators: The Gerber Foundation
• Investigators: Principal Investigator: Leslie Parker, PHD, University of Florida

Study record dates

Study Major Dates

• Study Start (Actual): November 23, 2023
• Primary Completion (Estimated): September 23, 2026
• Study Completion (Estimated): December 20, 2026

Study Registration Dates

• First Submitted: August 14, 2023
• First Submitted That Met QC Criteria: August 14, 2023
• First Posted (Actual): August 21, 2023

Study Record Updates

• Last Update Posted (Actual): March 6, 2024
• Last Update Submitted That Met QC Criteria: March 4, 2024
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Infections; Pneumonia; Lung Diseases; Disease Attributes; Infant, Newborn, Diseases; Cross Infection; Iatrogenic Disease; Lung Injury; Infant, Premature, Diseases; Ventilator-Induced Lung Injury; Healthcare-Associated Pneumonia; Bronchopulmonary Dysplasia; Pneumonia, Ventilator-Associated; Respiration Disorders; Respiratory Tract Diseases
• Other Study ID Numbers: 202101340

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No