Safety
prematurity
ADVERSE EVENTS, EVENT, COMPLICATIONS
Safety end-point measures will include incidence, severity, and causality of reported serious adverse events (SAEs), namely changes in the occurrence of expected common prematurity complications and clinical laboratory test assessments, and the development of unexpected SAEs in this high-risk population. All SAEs will be followed until satisfactory resolution is achieved or until the investigator responsible for the care of the participant deems the event to be chronic or the patient to be stable. All expected and unexpected SAEs, whether or not they are attributable to the study intervention, will be reviewed by the local principal investigators to determine if there is a reasonable suspected causal relationship to the intervention. If the relationship is reasonable, SAEs will be reported to chief investigators who will report to the Ethics Committee and request all investigators to guarantee the safety of all participants. There is no specific plan for auditing trial conduct.