Definitions of adverse events (AEs) and serious adverse events (SAEs)
deaths, death, necrotizing enterocolitis, candidiasis, insertion)Gastrointestinal hemorrhage, pulmonary hemorrhage, sepsis, respiratory death
NECROTIZING ENTEROCOLITIS, ADVERSE EVENTS, CANDIDIASIS, STERILE, PULMONARY HEMORRHAGE, SEPSIS
AEs and SAEs are assessed from randomization until death, primary hospital discharge, or 52 weeks’ PMA, whichever occurs sooner. AEs are:Spontaneous intestinal perforation (perforation not associated with necrotizing enterocolitis or other known pathology)*The need for cardiopulmonary resuscitation (chest compressions) and/or administration of adrenaline/epinephrine (for resuscitation) within 24 h of the intervention*Pneumothorax requiring drainage (needle thoracocentesis or intercostal catheter insertion)Gastrointestinal hemorrhage, defined as fresh blood aspirated from an indwelling gastric tube, during the 14 days after the first interventionClinical diagnosis of pulmonary hemorrhage within the first 48 h after the first interventionAny prescribed anti-hypertensive agents during the 14 days after the first interventionHyperglycemia > 10 mmol/L and/or receiving insulin therapy during the 14 days after the first interventionLate-onset sepsis after 48 h of age, defined as a positive bacterial or fungal culture from a normally sterile site, or negative blood culture but clinical suspicion of sepsis and treatment with antibiotic/antifungal medication for ≥ 5 days)Oral candidiasis during the first 14 days after the first intervention*Defined as serious adverse events (SAEs)In addition to the two SAEs above, all deaths before hospital discharge are defined as an SAE and are reviewed by the independent Data Safety Monitoring Board (DSMB) for relationship to the trial intervention and classified as a “respiratory death” or not.