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Purpose

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

Eligibility

Eligible Ages
Between 1 Hour and 3 Days
Eligible Sex
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.

Study Design

Phase
N/A
Study Type
Interventional
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).
Primary Purpose
Prevention
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

Arm Groups

ArmDescriptionAssigned Intervention
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.

Recruiting Locations

Neonatal intensive care unit at Shands children's hospital at the Univeristy of Florida
Gainesville, Florida 32504
Contact:
Leslie A Parker, PhD
352-215-9360
parkela@ufl.edu

More Details

Status
Recruiting
Sponsor
University of Florida

Study Contact

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

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.