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

Not Applicable

Recruiting

• Conditions: Ventilator Associated Pneumonia; Bronchopulmonary Dysplasia; Respiratory Disease
• Interventions: Procedure: Standardized oral Care

• Registration Number: NCT06000761
• Lead Sponsor: University of Florida

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.

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 Timeline

• Study First Submitted: 2023-08-14
• Study First Submitted QC: 2023-08-14
• Study First Posted: 2023-08-21
• Study Start: 2023-11-23
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-31
• Last Update Posted: 2025-04-01
• Primary Completion: 2026-09-23
• Study Completion: 2026-12-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 218

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Group 3	Standardized oral Care	Standardized oral care performed every 12 hours using sterile water.
Group 2	Standardized oral Care	Standardized oral care performed every 3-4 hours using sterile water.
Group 1	Standardized oral Care	Standardized oral care performed every 3-4 hours using human milk, donor or breast milk.

Primary Outcome Measures

Name	Time	Method
Number of participants with oral microbiome dysbiosis.	0-28 days	Oral samples will be obtained weekly and the microbiome analyzed using rRNA 16s sequencing

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Neonatal intensive care unit at Shands children's hospital at the Univeristy of Florida; 🇺🇸 Gainesville, Florida, United States