Study: NCT03169881

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 316 at risk

Adverse event: Placental transfusion syndrome
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 316 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 316 at risk

Adverse event: Ventricular dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 316 at risk

Adverse event: Newborn persistent pulmonary hypertension
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 316 at risk

Adverse event: Adrenal insufficiency
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 316 at risk

Adverse event: Abdominal distension
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 316 at risk

Adverse event: Oesophageal perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 316 at risk

Adverse event: Gastric perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 316 at risk

Adverse event: Ileal perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 316 at risk

Adverse event: Intra-abdominal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 316 at risk

Adverse event: Necrotising enterocolitis neonatal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 316 at risk

Adverse event: Neonatal intestinal perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 316 at risk

Adverse event: Pneumoperitoneum
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 316 at risk

Adverse event: Hepatic failure
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 316 at risk

Adverse event: Aspergillus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 316 at risk

Adverse event: Cytomegalovirus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 316 at risk

Adverse event: Enterovirus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 316 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 316 at risk

Adverse event: Klebsiella infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 316 at risk

Adverse event: Sepsis neonatal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 316 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 316 at risk

Adverse event: Sepsis neonatal
Serious: yes
Organ System: Infections and infestations
Frequency: 32 affected / 316 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 316 at risk

Adverse event: Stoma site haemorrhage
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 316 at risk

Adverse event: Hyperkalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 316 at risk

Adverse event: Cerebral haemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 316 at risk

Adverse event: Hydrocephalus
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 316 at risk

Adverse event: Intraventricular haemorrhage neonatal
Serious: yes
Organ System: Nervous system disorders
Frequency: 6 affected / 316 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 316 at risk

Adverse event: Oliguria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 316 at risk

Adverse event: Acute respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 316 at risk

Adverse event: Bronchopulmonary dysplasia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 316 at risk

Adverse event: Neonatal respiratory distress syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 316 at risk

Adverse event: Neonatal respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 316 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 316 at risk

Adverse event: Pulmonary haemorrhage
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 316 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 316 at risk

Adverse event: Hypertension neonatal
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 316 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 316 at risk

Adverse event: Thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 316 at risk

Adverse event: Sepsis neonatal
Serious: no
Organ System: Infections and infestations
Frequency: 16 affected / 316 at risk

Adverse event: Disseminated intravascular coagulation
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 325 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 325 at risk

Adverse event: Cardio-respiratory arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 325 at risk

Adverse event: Cardiopulmonary failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 325 at risk

Adverse event: Congenital anomaly
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 325 at risk

Adverse event: Newborn persistent pulmonary hypertension
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 325 at risk

Adverse event: Ileal perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 325 at risk

Adverse event: Necrotising enterocolitis neonatal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 325 at risk

Adverse event: Neonatal intestinal perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 325 at risk

Adverse event: Multiple organ dysfunction syndrome
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 325 at risk

Adverse event: Hyperbilirubinaemia
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 325 at risk

Adverse event: Cytomegalovirus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 325 at risk

Adverse event: Fungal infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 325 at risk

Adverse event: Klebsiella infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 325 at risk

Adverse event: Klebsiella sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 325 at risk

Adverse event: Sepsis neonatal
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 325 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 325 at risk

Adverse event: Pseudomonal sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 325 at risk

Adverse event: Sepsis neonatal
Serious: yes
Organ System: Infections and infestations
Frequency: 26 affected / 325 at risk

Adverse event: Pneumonia staphylococcal
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 325 at risk

Adverse event: Urosepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 325 at risk

Adverse event: CSF volume increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 325 at risk

Adverse event: Metabolic acidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 325 at risk

Adverse event: Intraventricular haemorrhage neonatal
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 325 at risk

Adverse event: Posthaemorrhagic hydrocephalus
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 325 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 325 at risk

Adverse event: Premature baby
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 325 at risk

Adverse event: Anuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 325 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 325 at risk

Adverse event: Acute lung injury
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 325 at risk

Adverse event: Acute respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 325 at risk

Adverse event: Neonatal respiratory distress syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 325 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 325 at risk

Adverse event: Pulmonary haemorrhage
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 325 at risk

Adverse event: Pulmonary hypertension
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 325 at risk

Adverse event: Pulmonary air leakage
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 325 at risk

Adverse event: Pulmonary arterial hypertension
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 325 at risk

Adverse event: Neonatal respiratory distress syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 325 at risk

Adverse event: Hypertension neonatal
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 325 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 325 at risk

Adverse event: Thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 325 at risk

Adverse event: Sepsis neonatal
Serious: no
Organ System: Infections and infestations
Frequency: 21 affected / 325 at risk