Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Randomized Controlled Trial of Surfactant Administration by Laryngeal Mask Airway (LMA)
Brief Summary: In this protocol we will conduct a randomized controlled trial where babies with respiratory distress syndrome (RDS) who have not yet reached criteria for intubation, will be randomized to receive surfactant by LMA or to continue receiving standard therapy of nasal CPAP and supplemental oxygen. All babies will be given surfactant by endotracheal tube if they reach "failure" criteria, which is the standard criterion for surfactant administration (i.e., FiO2= 65% while receiving nasal CPAP).

The objective of this RCT is to determine if surfactant can be successfully administered by LMA, thus perhaps avoiding the need for endotracheal intubation. The hypothesis is that fewer babies in the LMA group would reach failure criteria.


Options:
A: Arm Label: 1; Type: EXPERIMENTAL; Interventions: Device: Surfactant administered via Laryngeal Mask Airway (LMA) | Arm Label: 2; Type: OTHER; Interventions: Other: standard of care (nasal CPAP and supplemental oxygen) | Intervention Type: DEVICE; Name: Surfactant administered via Laryngeal Mask Airway (LMA); Assigned to Arm(s): 1 | Intervention Type: OTHER; Name: standard of care (nasal CPAP and supplemental oxygen); Assigned to Arm(s): 2
B: Arm Label: nCPAP Control Group; Type: ACTIVE_COMPARATOR; Interventions: Device: Nasal continuous positive airway pressure (nCPAP) | Arm Label: LMA Group; Type: EXPERIMENTAL; Interventions: Device: Nasal continuous positive airway pressure (nCPAP), Device: Laryngeal Mask Airway (LMA) to deliver surfactant, Drug: Surfactants, Pulmonary | Intervention Type: DEVICE; Name: Nasal continuous positive airway pressure (nCPAP); Assigned to Arm(s): LMA Group, nCPAP Control Group | Intervention Type: DEVICE; Name: Laryngeal Mask Airway (LMA) to deliver surfactant; Assigned to Arm(s): LMA Group | Intervention Type: DRUG; Name: Surfactants, Pulmonary; Assigned to Arm(s): LMA Group
C: Arm Label: Supraglottic airway; Type: EXPERIMENTAL; Interventions: Device: Supraglottic airway | Arm Label: Face-mask; Type: ACTIVE_COMPARATOR; Interventions: Device: Face-mask | Intervention Type: DEVICE; Name: Supraglottic airway; Assigned to Arm(s): Supraglottic airway | Intervention Type: DEVICE; Name: Face-mask; Assigned to Arm(s): Face-mask
D: 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

Answer: A