AUSTIN, Texas—St. David’s Medical Center Neonatal Intensive Care Unit (NICU) is participating in a clinical trial on necrotizing enterocolitis (NEC). NEC is a severe inflammatory disease of the gastrointestinal systems and is the leading cause of mortality in NICUs. The intestinal walls are suddenly attacked by pathogenic bacteria, resulting in necrosis, or tissue death in some of these walls. While the onset of NEC is unpredictable and acute, consequences of developing NEC can be life-long and range from short bowel syndrome and visual impairment, to cerebral palsy and abnormal growth.
NEC almost exclusively affects premature infants, as the lower birth weight and gestational age exposes them to a high risk for developing and dying from the disease. Although more than 5,000 infants in Europe and the US die every year from complications of NEC, a truly preventative measure has not yet been found. St. David’s NICU hopes to change this by providing beneficial, live bacteria to the premature infant’s gut before NEC develops. As NEC is thought to develop from blooms of dangerous bacteria, providing probiotics may give a preventative effect to the premature infant.
Sponsored by Infant Bacterial Therapeutics, the trial, named The Connection Study, will administer probiotics to low weight premature infants as a preventative measure against NEC. The Connection Study targets this potential treatment to those who are in highest need for it: lowest-weight premature infants. Under the direction of Dr. Anthony Rudine, principal investigator and NICU research medical director, clinicians will give daily doses of the probiotics (IBP-9414), and nutritional feedings to the infants until the infant reaches more than 34 weeks of age post-birth. Depending on the success of this trial, IBP-9414 could be a major beneficial therapy to St. David’s NICU, and premature infants globally.