Study: NCT01534481

Adverse event: Cardiac arrest neonatal
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 239 at risk

Adverse event: Heart disease congenital
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 239 at risk

Adverse event: Patent ductus arteriosus
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 239 at risk

Adverse event: Ascites
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 239 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 239 at risk

Adverse event: Infantile diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 239 at risk

Adverse event: Ileal stenosis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 239 at risk

Adverse event: Necrotising enterocolitis neonatal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 239 at risk

Adverse event: Neonatal intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 239 at risk

Adverse event: Neonatal intestinal perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 239 at risk

Adverse event: Pneumoperitoneum
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 239 at risk

Adverse event: Hyperbilirubinaemia neonatal
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 239 at risk

Adverse event: Neonatal cholestasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 239 at risk

Adverse event: Cytomegalovirus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 239 at risk

Adverse event: Disseminated aspergillosis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 239 at risk

Adverse event: Neonatal infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 239 at risk

Adverse event: Sepsis neonatal
Serious: yes
Organ System: Infections and infestations
Frequency: 14 affected / 239 at risk

Adverse event: Metabolic acidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 239 at risk

Adverse event: Hypoglycaemia neonatal
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 239 at risk

Adverse event: Osteopenia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 239 at risk

Adverse event: Haemorrhage intracranial
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 239 at risk

Adverse event: Hypoxic-ischaemic encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 239 at risk

Adverse event: Intraventricular haemorrhage neonatal
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 239 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 239 at risk

Adverse event: Chronic kidney disease
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 239 at risk

Adverse event: Renal failure neonatal
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 239 at risk

Adverse event: Renal tubular acidosis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 239 at risk

Adverse event: Bronchopulmonary dysplasia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 239 at risk

Adverse event: Neonatal respiratory distress
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 239 at risk

Adverse event: Neonatal respiratory distress syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 239 at risk

Adverse event: Neonatal respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 239 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 239 at risk

Adverse event: Pulmonary air leakage
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 239 at risk

Adverse event: Pulmonary haemorrhage neonatal
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 239 at risk

Adverse event: Pulmonary hypertension
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 239 at risk

Adverse event: Patent ductus arteriosus
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 2 affected / 239 at risk

Adverse event: Retinopathy of prematurity
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 239 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 239 at risk

Adverse event: Necrotising enterocolitis neonatal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 239 at risk

Adverse event: Cytomegalovirus infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 239 at risk

Adverse event: Sepsis neonatal
Serious: no
Organ System: Infections and infestations
Frequency: 13 affected / 239 at risk

Adverse event: Feeding intolerance
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 239 at risk

Adverse event: Metabolic acidosis
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 239 at risk

Adverse event: Hypoglycaemia neonatal
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 239 at risk

Adverse event: Apnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 239 at risk

Adverse event: Infantile apnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 239 at risk

Adverse event: Bradycardia neonatal
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 244 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 244 at risk

Adverse event: Renal hypoplasia
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 244 at risk

Adverse event: Necrotising enterocolitis neonatal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 20 affected / 244 at risk

Adverse event: Neonatal intestinal perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 244 at risk

Adverse event: Adenovirus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 244 at risk

Adverse event: CNS ventriculitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 244 at risk

Adverse event: Cytomegalovirus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 244 at risk

Adverse event: Gastroenteritis rotavirus
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 244 at risk

Adverse event: Neonatal pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 244 at risk

Adverse event: Nosocomial infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 244 at risk

Adverse event: Rhinovirus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 244 at risk

Adverse event: Sepsis neonatal
Serious: yes
Organ System: Infections and infestations
Frequency: 14 affected / 244 at risk

Adverse event: Urinary tract infection fungal
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 244 at risk

Adverse event: Feeding intolerance
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 244 at risk

Adverse event: Cerebral ventricle dilatation
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 244 at risk

Adverse event: Neonatal seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 244 at risk

Adverse event: Renal failure neonatal
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 244 at risk

Adverse event: Neonatal respiratory distress
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 244 at risk

Adverse event: Neonatal respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 244 at risk

Adverse event: Pulmonary hypertension
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 244 at risk

Adverse event: Labile blood pressure
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 244 at risk

Adverse event: Neonatal hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 244 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 244 at risk

Adverse event: Necrotising enterocolitis neonatal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 244 at risk

Adverse event: Acute on chronic liver failure
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 244 at risk

Adverse event: Neonatal cholestasis
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 244 at risk

Adverse event: Coronavirus infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 244 at risk

Adverse event: Cytomegalovirus infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 244 at risk

Adverse event: Gastroenteritis rotavirus
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 244 at risk

Adverse event: Metapneumovirus infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 244 at risk

Adverse event: Neonatal infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 244 at risk

Adverse event: Sepsis neonatal
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 244 at risk

Adverse event: Staphylococcal infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 244 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 244 at risk

Adverse event: Intraventricular haemorrhage neonatal
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 244 at risk

Adverse event: Neonatal seizure
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 244 at risk

Adverse event: Hypothermia neonatal
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 244 at risk

Adverse event: Neonatal anuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 244 at risk

Adverse event: Neonatal respiratory distress
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 244 at risk

Adverse event: Hypertension neonatal
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 244 at risk