Patient monitoring
diarrhea, vomiting, hypotension, sepsis, gastro-intestinal disturbances
NECROTIZING ENTEROCOLITIS, ADVERSE EVENT, GASTROINTESTINAL BLEEDING, ADVERSE EVENT, SEPSIS
Vital signs (heart rate, respiratory rate, temperature, blood pressure, and oxygen saturation) and respiratory support (FiOL-citrulline administration carries a theoretical risk of systemic hypotension. An adverse drop in blood pressure was defined as a decrease in mean arterial blood pressure of more than 25% of baseline blood pressure. Enterally administered medications carry the risk of causing gastro-intestinal disturbances, such as vomiting and diarrhea. Therefore, participants were monitored for clinical evidence of feeding intolerance (including vomiting and diarrhea), necrotizing enterocolitis, and gastrointestinal bleeding. Participants were also monitored for clinical evidence of sepsis. Adverse events were recorded during treatment and within 48 h at the end of treatment. The Principal Investigator determined any potential relationship to L-citrulline treatment. In addition, a data safety monitoring committee reviewed each adverse event and its relationship to L-citrulline. An interim safety analysis was undertaken after the first 3 participants were enrolled and after a total of 6 participants were enrolled.