Clinical trial NCT06000761: Frequent Standardized Oral Care Using Human Milk in the Neonatal Intensive Care Unit
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ventilator Associated Pneumonia
Bronchopulmonary Dysplasia
Respiratory Disease
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: The Gerber Foundation
First posted: 2023-08-21
Enrollment: 218
Sex: ALL
Minimum age (years): 1
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
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

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.

Eligibility 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.

Primary outcomes:
measure: Number of participants with oral microbiome dysbiosis.
timeFrame: 0-28 days
Secondary outcomes:
measure: Number of participants with ventilator associated pneumonia
timeFrame: 0-28 days
measure: Number of participants with bronchopulmonary dysplasia
timeFrame: 0-60 days
measure: Number of days requiring respiratory support
timeFrame: 0-60 days
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: Neonatal intensive care unit at Shands children's hospital at the Univeristy of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Leslie Parker, PHD
role: PRINCIPAL_INVESTIGATOR
References: