Thanks to the leadership of Mark Underwood, chief of neonatology at UC Davis Children's Hospital, and the NEC Society's Scientific Advisory Council, the NEC Society is launching a Multi-NICU Probiotic Quality Improvement (QI) Project. It is the first project of its kind to capture data from neonatal intensive care units (NICUs), that are ready to start routine administration of probiotics to very low birthweight infants at risk for necrotizing enterocolitis.
Necrotizing enterocolitis (NEC) is a leading cause of death in premature infants, with case-fatality rates of 20 to 30 percent. For fragile and premature infants in the NICU, NEC is a relatively common disease of the intestinal tract in which the tissue lining the intestine becomes inflamed and dies. It is the most common, serious gastrointestinal disease affecting newborn infants, and is considered a medical, and oftentimes a surgical, emergency.
Providing mothers' milk to premature infants helps to reduce the NEC risks by fostering a healthy gut microbiome. There is also solid empirical evidence demonstrating improved outcomes in fragile neonates with probiotic administration, including decreased risk of necrotizing enterocolitis, death and feeding intolerance. Yet despite probiotics' promising protective qualities for preemies, many NICUs are not utilizing this potentially lifesaving intervention.
The NEC Society's Probiotic QI Project seeks to change this.
Three probiotic products have been selected, based on the literature and on testing conducted at UC Davis.
"This project is the result of feedback gathered at the 2017 Necrotizing Enterocolitis Symposium, presented by the NEC Society and the UC Davis Department of Pediatrics. Many NICU representatives voiced interest in offering probiotics to their most fragile and premature patients, but did not know where or how to begin this intervention," said Jennifer Canvasser, founder and executive director of the NEC Society.
Participating NICUs can choose which product they use (they can also choose a different product if they wish). Those who participate will collect data before, during and after probiotics are administered. They then will share the de-identified data with the NEC Society for eventual publication. The goal is to have the participation of approximately 100 NICUs.
"We hope that this novel project will help empower more NICUs to use probiotics to improve outcomes and reduce risks of necrotizing enterocolitis, death and feeding intolerance among our most vulnerable babies," said Underwood.
This is not a clinical trial and there is no placebo arm, no randomization and no blinding, he added.
The results of this multi-center QI project will be shared with clinicians and researchers. The more NICUs that provide the secondary outcomes data, the more robust the final published data will be to improve the care of very low birthweight babies.
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