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

University of Florida

Status: Enrolling

Conditions: Ventilator Associated Pneumonia; Respiratory Disease; Bronchopulmonary Dysplasia

Treatments: Procedure: Standardized oral Care

Study type: Interventional

Funder types: Other

Identifiers

NCT06000761

202101340

Details and patient eligibility

About

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.

Full 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.

Enrollment: 218 estimated patients

Sex: All

Ages: 1 hour to 3 days old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Single Blind

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218 participants in 3 patient groups

Group 1

Active Comparator group

Description:

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

Treatment:

Procedure: Standardized oral Care

Group 2

Active Comparator group

Description:

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

Treatment:

Procedure: Standardized oral Care

Group 3

Active Comparator group

Description:

Standardized oral care performed every 12 hours using sterile water.

Treatment:

Procedure: Standardized oral Care