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NCT06000761NARecruiting

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

University of Florida

Start Date

11/23/2023

Completion Date

12/20/2026

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.

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.

Eligibility Criteria

Age Range: No minimum to No maximum

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.

Interventions

PROCEDURE

Standardized oral Care

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Conditions

Ventilator Associated PneumoniaBronchopulmonary DysplasiaRespiratory Disease

Locations

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

Gainesville, Florida 32504

United States