Name of the trial | Acronym | Number recruited | Study population | Description of the trial (P: population, I: intervention, C: control, O: outcome) | Outcome |
---|---|---|---|---|---|
CATheter infections in Children25 | CATCH | 1484 | Paediatrics | P: children in PICU I: heparin-bonded or antibiotic impregnated central venous catheters (CVC) C: standard CVC O: hospital-acquired blood stream infection | Recruitment completed Pending publication |
Control of Hyperglycaemia in Paediatric intensive care14 | CHiP | 1369 | Paediatrics | P: ventilated children in PICU receiving vasoactive support I: tight glycaemic control C: standard treatment O: ventilator-free days | No significant difference in outcomes |
Fluid Expansion As Supportive Therapy26 | FEAST | 3141 | Paediatrics | P: children with severe febrile illness and impaired perfusion in three African countries I: normal saline bolus or 5% albumin bolus C: no fluid bolus O: 48-h mortality | Fluid boluses significantly increased 48-h mortality |
HYpothermia Pediatric Head Injury Trial49 | HyP-HIT | 225 | Paediatrics | P: children with severe TBI within 8 h of injury I: hypothermia (32.5°C) for 24 h C: normothermia O: unfavourable outcome at 6 months | Hypothermia therapy did not improve the neurologic outcome and may increase mortality |
REsearching severe Sepsis and Organ dysfunction in children: a gLobal PerspectiVE46 | RESOLVE | 477 | Paediatrics | P: children with sepsis-induced cardiovascular and respiratory failure I: drotrecogin alfa infusion C: placebo infusion O: composite time to complete organ failure resolution (CTCOFR) | No significant differences in CTCOFR or mortality More central nervous system bleeds in treatment group |
Safe Paediatric Euglycaemia after Cardiac Surgery44 | SPECS | 980 | Paediatrics | P: young children after cardiac surgery with cardiopulmonary bypass I: tight glycaemic control C: standard care O: rate of healthcare-associated infections | No significant differences in outcome |
Therapeutic Hypothermia after Paediatric Cardiac arrest (IH: in-hospital arrest; OH: out-of-hospital arrest)35 | THAPCA (THAPCA-IH and THAPCA-OH) | >750 | Paediatrics | P: children undergoing mechanical ventilation after cardiac arrest >2 min I: therapeutic hypothermia (32–34°C) for 48 h C: therapeutic normothermia O: survival with good neurobehavioural follow-up at 12 months | IH: recruitment ongoing OH: recruitment completed. Pending publication |
Transfusion Requirements In the PICU47 | TRIPICU | 637 | Paediatrics | P: stable children in PICU I: restrictive transfusion strategy (target >7 g/dL) C: liberal strategy (target >9.5 g/dL) O: new or progressive multiple-organ dysfunction syndrome | Restrictive transfusion strategy decreased transfusion requirements without increasing adverse outcomes |
SUrfactant, Positive pressure and Pulse Oximetry Randomised Trial16 | SUPPORT | 1316 | Neonates | oximetry part: P: infants born between 24 and 28 weeks of gestation I: lower target oxygen saturation (85–89%) C: higher target (91–95%) O: composite outcome of severe retinopathy of prematurity or death | Lower oximetry target range did not significantly decrease the composite outcome of severe retinopathy or death, but increased mortality |
DEcompressive CRAniectomy in diffuse traumatic brain injury48 | DECRA | 155 | Adults; children>15 years included | P: adults and children >15 with TBI in whom first-tier intensive care and neurosurgical therapies had not maintained intracranial pressure below accepted targets I: decompressive craniectomy C: standard care O: Extended Glasgow Outcome scale score | Decompressive craniectomy decreased intracranial pressure but was associated with more unfavourable outcomes |
Clinical Randomisation of an Antifibrinolytic in Significant Haemorrhage trial20 | CRASH-2 | 20 211 | Adults | P: adult trauma patients with or at risk of significant bleeding I: tranexamic acid C: placebo O: death within 4 weeks of injury | Significant reduction in all-cause mortality and death due to bleeding with tranexamic acid |
PICU, paediatric intensive care units; TBI, traumatic brain injury.