Study: NCT01778634

Adverse event: Respiratory distress
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 61 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 61 at risk

Adverse event: Apnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Breathing pause \> 20 seconds
Frequency: 4 affected / 61 at risk

Adverse event: Patent ductus arteriosus
Serious: yes
Organ System: Cardiac disorders
Notes: Patent ductus arteriosus confirmed by cardiac echocardiography
Frequency: 12 affected / 61 at risk

Adverse event: Necrotising colitis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Necrotizing enterocolitis Bell Stage ≥2
Frequency: 3 affected / 61 at risk

Adverse event: Intestinal perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 61 at risk

Adverse event: Cholestasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 5 affected / 61 at risk

Adverse event: Retinopathy of prematurity
Serious: yes
Organ System: Eye disorders
Notes: Retinopathy of prematurity (ROP) \>Stage 2
Frequency: 3 affected / 60 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: hematocrit \<25
Frequency: 6 affected / 61 at risk

Adverse event: White blood cell count >40,000 cells/mm3
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 61 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: platelet count \<50,000
Frequency: 2 affected / 61 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Notes: Positive culture from a sterile site (blood or spinal fluid)
Frequency: 9 affected / 61 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 61 at risk

Adverse event: Blood Urea Nitrogen > 60 mg/dL
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 61 at risk

Adverse event: Hypercalcaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Serum calcium level \>12.2 mg/dL
Frequency: 2 affected / 61 at risk

Adverse event: Hypernatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Serum sodium \>155 mEq/L
Frequency: 2 affected / 61 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Serum sodium \<121 mEq/L
Frequency: 1 affected / 61 at risk

Adverse event: IV site reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 61 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 61 at risk

Adverse event: Gastric residual >50% volume of feed
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 61 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Notes: Abdominal girth increase \> 2cm from baseline
Frequency: 2 affected / 61 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: stool consistency change with more water content \<48 h duration
Frequency: 1 affected / 61 at risk

Adverse event: Oral candidiasis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 61 at risk

Adverse event: Leukocytosis
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: white blood cell count \>20,000 and \<40,000 cells/mm3
Frequency: 12 affected / 61 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: platelet count \<100,000 and \>50,000 cells/mm3
Frequency: 12 affected / 61 at risk

Adverse event: conjugated hyperbilirubinemia
Serious: no
Organ System: Hepatobiliary disorders
Notes: Direct bilirubin 1.0-2.0 mg/dL
Frequency: 14 affected / 61 at risk

Adverse event: Elevated serum creatinine
Serious: no
Organ System: Renal and urinary disorders
Notes: Serum creatinine 1.3-2.3 mg/dL
Frequency: 1 affected / 61 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: hematocrit \<35% and \>25%
Frequency: 16 affected / 61 at risk

Adverse event: Metabolic acidosis
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Serum bicarbonate \<22 and \>14 mEq/L
Frequency: 18 affected / 61 at risk

Adverse event: Metabolic alkalosis
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Serum bicarbonate \>30 and \<46 mEq/L
Frequency: 6 affected / 61 at risk

Adverse event: Elevated Blood Urea Nitrogen
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Serum BUN \>27 and \<60 mg/dL
Frequency: 28 affected / 61 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Serum potassium \>5.5 and \<6.9 mEq/L
Frequency: 21 affected / 61 at risk

Adverse event: Hyperbilirubinaemia
Serious: no
Organ System: Hepatobiliary disorders
Notes: Total bilirubin \> 7 and \<14 mg/dL
Frequency: 7 affected / 61 at risk

Adverse event: Hypernatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Serum sodium \<132 and \>120 mEq/dL
Frequency: 8 affected / 61 at risk

Adverse event: Respiratory distress
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 60 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Apnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Breathing pause \> 20 seconds
Frequency: 3 affected / 60 at risk

Adverse event: Patent ductus arteriosus
Serious: yes
Organ System: Cardiac disorders
Notes: Patent ductus arteriosus confirmed by cardiac echocardiography
Frequency: 17 affected / 60 at risk

Adverse event: Necrotising colitis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Necrotizing enterocolitis Bell Stage ≥2
Frequency: 3 affected / 60 at risk

Adverse event: Intestinal perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 60 at risk

Adverse event: Ileal stenosis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Cholestasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 5 affected / 60 at risk

Adverse event: Retinopathy of prematurity
Serious: yes
Organ System: Eye disorders
Notes: Retinopathy of prematurity (ROP) \>Stage 2
Frequency: 11 affected / 58 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: hematocrit \<25
Frequency: 5 affected / 60 at risk

Adverse event: White blood cell count >40,000 cells/mm3
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 60 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: platelet count \<50,000
Frequency: 2 affected / 60 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Notes: Positive culture from a sterile site (blood or spinal fluid)
Frequency: 6 affected / 60 at risk

Adverse event: Hypochloraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Serum chloride \<80 mEq/L
Frequency: 1 affected / 60 at risk

Adverse event: Hypernatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Serum sodium \>155 mEq/L
Frequency: 1 affected / 60 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Serum potassium \<2.4 mEq/L
Frequency: 2 affected / 60 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Serum sodium \<121 mEq/L
Frequency: 1 affected / 60 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 60 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Gastric residual >50% volume of feed
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 60 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Notes: Abdominal girth increase \> 2cm from baseline
Frequency: 3 affected / 60 at risk

Adverse event: Leukocytosis
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: white blood cell count \>20,000 and \<40,000 cells/mm3
Frequency: 11 affected / 60 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: platelet count \<100,000 and \>50,000 cells/mm3
Frequency: 4 affected / 60 at risk

Adverse event: Abnormal liver function test
Serious: no
Organ System: Hepatobiliary disorders
Notes: Serum liver function test (AST/ALT/ or alkaline phosphatase) 1.5-3.5X normal value
Frequency: 1 affected / 60 at risk

Adverse event: conjugated hyperbilirubinemia
Serious: no
Organ System: Hepatobiliary disorders
Notes: Direct bilirubin 1.0-2.0 mg/dL
Frequency: 8 affected / 60 at risk

Adverse event: Elevated serum creatinine
Serious: no
Organ System: Renal and urinary disorders
Notes: Serum creatinine 1.3-2.3 mg/dL
Frequency: 2 affected / 60 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: hematocrit \<35% and \>25%
Frequency: 12 affected / 60 at risk

Adverse event: Metabolic acidosis
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Serum bicarbonate \<22 and \>14 mEq/L
Frequency: 19 affected / 60 at risk

Adverse event: Metabolic alkalosis
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Serum bicarbonate \>30 and \<46 mEq/L
Frequency: 8 affected / 60 at risk

Adverse event: Elevated Blood Urea Nitrogen
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Serum BUN \>27 and \<60 mg/dL
Frequency: 26 affected / 60 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Serum potassium \>5.5 and \<6.9 mEq/L
Frequency: 20 affected / 60 at risk

Adverse event: Hyperbilirubinaemia
Serious: no
Organ System: Hepatobiliary disorders
Notes: Total bilirubin \> 7 and \<14 mg/dL
Frequency: 9 affected / 60 at risk

Adverse event: Hypernatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Serum sodium \<132 and \>120 mEq/dL
Frequency: 13 affected / 60 at risk