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

Bronchopulmonary Dysplasia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06000761
• Other study ID #: 202101340
• Status: Recruiting
• Phase: N/A
• Start date: November 23, 2023
• Est. completion date: December 20, 2026

Study information

• Verified date: November 2023
• Source: University of Florida
• Contact: Leslie A Parker, PhD, APRN
• Phone: 352-273-6384
• Email: parkela[@]ufl.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 218
• Est. completion date: December 20, 2026
• Est. primary completion date: September 23, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Hour to 3 Days

Eligibility

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.

Related Conditions & MeSH terms

• Bronchopulmonary Dysplasia
• Pneumonia, Ventilator-Associated
• Respiration Disorders
• Respiratory Disease
• Respiratory Tract Diseases
• Ventilator Associated Pneumonia

Intervention

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.

Locations

Country	Name	City	State
United States	Neonatal intensive care unit at Shands children's hospital at the Univeristy of Florida	Gainesville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	The Gerber Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with oral microbiome dysbiosis.	Oral samples will be obtained weekly and the microbiome analyzed using rRNA 16s sequencing	0-28 days
Secondary	Number of participants with ventilator associated pneumonia	Evidence of ventilator pneumonia will be assessed weekly over the first 4 weeks of life	0-28 days
Secondary	Number of participants with bronchopulmonary dysplasia	Evidence of bronchopulmonary dysplasia will be assessed weekly over the first 60 days of life	0-60 days
Secondary	Number of days requiring respiratory support	Days the infant was on any type of respiratory support will be assessed daily for the first 60 days of life	0-60 days