Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Efficacy of Rescue Surfactant Delivery Via Endotracheal Intubation (INSURE Technique) Versus Laryngeal Mask Airway (LMA) for Respiratory Distress Syndrome (RDS) in Preterm Neonates
Brief Summary: In this study, newborn babies with respiratory distress syndrome (RDS), receiving oxygen via nasal continuous airway pressure (CPAP) modalities, and needing surfactant treatment will be randomized to standard delivery of surfactant via and endotracheal tube airway (inserted after pre-medication for pain with a short-acting narcotic), or to surfactant delivery via laryngeal mask airway (LMA). The intent is to remove the airways and return babies to non-invasive CPAP support, after surfactant is given. The primary outcome measure is the rate of failure of initial surfactant therapy. Standardized failure criteria are reached: a) early, if the baby is unable to be placed back on non-invasive CPAP (i.e., needs tracheal intubation and mechanical ventilation) or, b) late, if the baby requires ventilation, retreatment with surfactant within 8 hours or more than 2 doses of surfactant.

The objective of this protocol is to reduce the need for endotracheal intubation and mechanical ventilation in preterm neonates with RDS needing rescue surfactant therapy by instilling surfactant though an LMA, while achieving comparable efficacy of surfactant treatment.

The hypothesis is that surfactant treatment through an LMA will decrease the proportion of babies with RDS who require mechanical ventilation or subsequent intubation, when compared to standard surfactant treatment following endotracheal intubation with sedation.


Options:
A: 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
B: 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
C: Arm Label: Endotracheal intubation; Type: ACTIVE_COMPARATOR; Interventions: Device: Endotracheal intubation, Drug: remifentanil | Arm Label: Laryngeal mask airway; Type: EXPERIMENTAL; Interventions: Device: Laryngeal mask airway | Intervention Type: DEVICE; Name: Endotracheal intubation; Assigned to Arm(s): Endotracheal intubation | Intervention Type: DEVICE; Name: Laryngeal mask airway; Assigned to Arm(s): Laryngeal mask airway | Intervention Type: DRUG; Name: remifentanil; Assigned to Arm(s): Endotracheal intubation
D: 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

Answer: C