Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Multicentre Randomised Controlled Trial of Minimally-invasive Surfactant Therapy in Preterm Infants 25-28 Weeks Gestation on Continuous Positive Airways Pressure
Brief Summary: Trial question: Does administration of exogenous surfactant using a minimally-invasive technique improve outcome in preterm infants 25-28 weeks gestation treated with continuous positive airway pressure (CPAP)? Trial hypothesis: That early surfactant administration via a minimally-invasive technique to preterm infants on CPAP will result in a lesser duration of mechanical respiratory support, and a higher incidence of survival without bronchopulmonary dysplasia. Trial design: Multicentre, randomised, masked, controlled trial in inborn preterm infants 25-28 weeks gestation, aged less than 6 hours, requiring CPAP because of respiratory distress, with an FiO2 of \>=0.3 and CPAP pressure 5-8. Infants randomised to surfactant treatment receive 200 mg/kg of poractant alfa (Curosurf) administered under direct laryngoscopy using a surfactant instillation catheter, followed by reinstitution of CPAP. Controls continue on CPAP. The intervention is masked from the clinical team. Care thereafter is as per usual in both groups, other than the requirement to adhere to intubation criteria. The primary outcome is incidence of death or BPD. Secondary outcomes include incidence of death, major neonatal morbidities (BPD, intraventricular haemorrhage, periventricular leukomalacia, retinopathy of prematurity, necrotising enterocolitis), pneumothorax and patent ductus arteriosus; need for intubation and surfactant therapy; durations of mechanical respiratory support, intubation, CPAP, intubation and CPAP, high flow nasal cannula (HFNC), oxygen therapy, intensive care stay and hospitalisation; hospitalisation cost; applicability and safety of the MIST procedure; and outcome at 2 years. The sample size is 303/group, allowing detection of a 33% difference in the primary outcome with 90% power. The trial commenced at Royal Hobart Hospital December 2011 and Royal Women's Hospital during 2012, and will ultimately be conducted over 5 years in multiple centres internationally.


Options:
A: Arm Label: Minimally invasive surfactant therapy; Type: ACTIVE_COMPARATOR; Interventions: Device: Minimally invasive surfactant therapy | Arm Label: Continuation on CPAP; Type: SHAM_COMPARATOR; Interventions: Other: Continuation on CPAP | Intervention Type: DEVICE; Name: Minimally invasive surfactant therapy; Assigned to Arm(s): Minimally invasive surfactant therapy | Intervention Type: OTHER; Name: Continuation on CPAP; Assigned to Arm(s): Continuation on CPAP
B: Arm Label: PS Group; Type: ACTIVE_COMPARATOR; Interventions: Drug: PS Group | Arm Label: NCPAP Group; Type: EXPERIMENTAL; Interventions: Device: NCPAP Group | Arm Label: ISX Group; Type: EXPERIMENTAL; Interventions: Drug: ISX Group | Intervention Type: DRUG; Name: PS Group; Assigned to Arm(s): PS Group | Intervention Type: DEVICE; Name: NCPAP Group; Assigned to Arm(s): NCPAP Group | Intervention Type: DRUG; Name: ISX Group; Assigned to Arm(s): ISX Group
C: Arm Label: Surfactant and Low Oxygen; Type: EXPERIMENTAL; Interventions: Drug: Surfactant, Drug: Supplemental oxygen with target saturation of 85 to 89% | Arm Label: Surfactant and High Oxygen; Type: EXPERIMENTAL; Interventions: Drug: Surfactant, Drug: Supplemental oxygen with target saturation of 91 to 95% | Arm Label: CPAP and Low Oxygen; Type: EXPERIMENTAL; Interventions: Device: Continuous Positive Airway Pressure (CPAP), Drug: Supplemental oxygen with target saturation of 85 to 89% | Arm Label: CPAP and High Oxygen; Type: EXPERIMENTAL; Interventions: Device: Continuous Positive Airway Pressure (CPAP), Drug: Supplemental oxygen with target saturation of 91 to 95% | Intervention Type: DRUG; Name: Surfactant; Assigned to Arm(s): Surfactant and High Oxygen, Surfactant and Low Oxygen | Intervention Type: DEVICE; Name: Continuous Positive Airway Pressure (CPAP); Assigned to Arm(s): CPAP and High Oxygen, CPAP and Low Oxygen | Intervention Type: DRUG; Name: Supplemental oxygen with target saturation of 85 to 89%; Assigned to Arm(s): CPAP and Low Oxygen, Surfactant and Low Oxygen | Intervention Type: DRUG; Name: Supplemental oxygen with target saturation of 91 to 95%; Assigned to Arm(s): CPAP and High Oxygen, Surfactant and High Oxygen
D: Arm Label: Nasal Continuous Positive Airway Pressure (CPAP); Type: ACTIVE_COMPARATOR; Interventions: Device: Nasal CPAP (SLE) | Arm Label: Nasal Intermittent Mandatory Ventilation (IMV); Type: ACTIVE_COMPARATOR; Interventions: Device: Nasal IMV (SLE) | Intervention Type: DEVICE; Name: Nasal CPAP (SLE); Assigned to Arm(s): Nasal Continuous Positive Airway Pressure (CPAP) | Intervention Type: DEVICE; Name: Nasal IMV (SLE); Assigned to Arm(s): Nasal Intermittent Mandatory Ventilation (IMV)

Answer: A