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

• ClinicalTrials.gov Identifier: NCT06000761
• Recruitment Status: Recruiting
• First Posted: August 21, 2023
• Last Update Posted: March 6, 2024
• Sponsor: University of Florida
• Collaborator: The Gerber Foundation
• Information provided by (Responsible Party): University of Florida

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Ventilator Associated Pneumonia; Bronchopulmonary Dysplasia; Respiratory Disease	Procedure: Standardized oral Care	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 218 participants
• Allocation: Randomized
• Intervention Model: Sequential Assignment
• Intervention Model Description: 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).
• Masking: Single (Outcomes Assessor)
• Masking Description: 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
• Primary Purpose: Prevention
• 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
• Actual Study Start Date: November 23, 2023
• Estimated Primary Completion Date: September 23, 2026
• Estimated Study Completion Date: December 20, 2026

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Number of participants with oral microbiome dysbiosis. [ Time Frame: 0-28 days ]
   Oral samples will be obtained weekly and the microbiome analyzed using rRNA 16s sequencing

Secondary Outcome Measures :

1. Number of participants with ventilator associated pneumonia [ Time Frame: 0-28 days ]
   Evidence of ventilator pneumonia will be assessed weekly over the first 4 weeks of life
2. Number of participants with bronchopulmonary dysplasia [ Time Frame: 0-60 days ]
   Evidence of bronchopulmonary dysplasia will be assessed weekly over the first 60 days of life
3. Number of days requiring respiratory support [ Time Frame: 0-60 days ]
   Days the infant was on any type of respiratory support will be assessed daily for the first 60 days of life

Eligibility Criteria

• Ages Eligible for Study: 1 Hour to 3 Days (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Contacts

Contact: Leslie A Parker, PhD, APRN; 352-273-6384; parkela@ufl.edu

Locations

United States, Florida

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

Gainesville, Florida, United States, 32504

Contact: Leslie A Parker, PhD 352-215-9360 parkela@ufl.edu

Principal Investigator: Leslie A Parker, PhD

Sponsors and Collaborators

University of Florida

The Gerber Foundation

Investigators

• Principal Investigator: Leslie Parker, PHD; University of Florida

  Study Documents (Full-Text)

Documents provided by University of Florida:

Study Protocol  [PDF] August 23, 2023

More Information

• Responsible Party: University of Florida
• ClinicalTrials.gov Identifier: NCT06000761
• Other Study ID Numbers: 202101340
• First Posted: August 21, 2023
• Last Update Posted: March 6, 2024
• Last Verified: November 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Pneumonia, Ventilator-Associated; Respiratory Tract Diseases; Respiration Disorders; Bronchopulmonary Dysplasia; Pneumonia; Respiratory Tract Infections; Infections; Lung Diseases; Healthcare-Associated Pneumonia; Cross Infection; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Ventilator-Induced Lung Injury; Lung Injury; Infant, Premature, Diseases; Infant, Newborn, Diseases