Frequent Standardized Oral Care Using Human Milk to Reduce Gastrointestinal Dysbiosis and Inflammation to Improve Health Outcomes and Reduce Cost in Preterm Very Low Birth Weight Infants

/Abstract In critically ill adults, evidence based guidelines for oral care are well established and known to reduce complications.1 However, in preterm infants admitted to the neonatal intensive care unit (NICU), no such guidelines exist and there is a dearth of information regarding oral care for preterm VLBW (< 1500 grams at birth) infants who because of their suppressed immunity and physiologic immaturity, are at increased risk of morbidity due to infrequent and non-standardized oral care.2 The optimal frequency and element to use for oral care to decrease oral/intestinal inflammation and microbial dysbiosis and to decrease cost of care is unknown. The overall objective of this 3-year study is to determine whether frequent standardized oral care using human milk reduces oral/intestinal inflammation and microbial dysbiosis (decreased beneficial bacteria; increased potentially pathogenic bacteria; decreased alpha diversity) leading to improved neonatal outcomes thus reducing cost of care. Previously collected oral and stool samples will be analyzed for inflammatory markers, metagenomic composition, and the cost and cost effectiveness of the intervention will be determined. The proposed study is a secondary analysis of data from an ongoing prospective randomized controlled trial of 168 racially diverse male and female preterm VLBW infants. Infants are randomized into 1 of 3 groups. Oral care is provided every 3-4 hours using human milk (Group 1); every 3-4 hours using sterile water (Group 2); and every 12 hours using sterile water (Group 3: standard care) for 4 weeks after birth. Aim 1 will evaluate the effect of frequent standardized oral care using human milk on oral inflammation in preterm VLBW infants. For Aim 2, we will characterize the metagenomic composition of oral and stool samples and their impact on inflammatory profiles. Aim 3 will determine the cost and cost effectiveness of frequent oral care using human milk. Results are expected to fill an important gap in research regarding frequent standardized oral care using human milk and whether it decreases oral/intestinal inflammation and dysbiosis and reduces cost of care. Project Number: 1R56DE034473-01 | Fiscal Year: 2025 | NIH Institute/Center: National Institute of Dental and Craniofacial Research (NIDCR) | Principal Investigator: Leslie Parker (+1 co-PI) | Institution: UNIVERSITY OF FLORIDA, GAINESVILLE, FL | Award Amount: $511,706 | Activity Code: R56 | Study Section: Pregnancy and Neonatology Study Section[PN] View on NIH RePORTER: https://reporter.nih.gov/project-details/11390508