Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Neonatal Supraglottic Airway Trial: A Single-centre, Open-label, Randomized Clinical Trial to Evaluate the Efficacy of I-gel® Supraglottic Airway Used in Neonatal Resuscitation in Reducing Early Neonatal Mortality and Morbidity
Brief Summary: Mortality rates from birth asphyxia in low-income countries remain very high. Face mask ventilation (FMV) is the most common method of resuscitating neonates in such settings. It is mostly performed by midwives but may not always be satisfactory. The i-gel® is a cuffless supraglottic airway which is easy to insert and provides an efficient seal that prevents air leakage with the potential to enhance the performance of neonatal resuscitation. Midwives can be trained in a short time to use this method. A pilot study in Uganda has demonstrated that midwives can safely perform resuscitation of newborn with the i-gel.

OBJECTIVE To investigate whether the use of a cuffless supraglottic airway compared to face-mask ventilation during neonatal resuscitation can reduce early neonatal death (before 7 days of life) or morbidity in neonatal encephalopathy (NE) in asphyxiated neonates.

STUDY DESIGN, SETTING AND POPULATION A single-centre randomized clinical trial will be conducted at Mulago National Referral Hospital, Kampala, Uganda, among asphyxiated neonates in the delivery units. Prior to the intervention, all staff in the labour ward performing resuscitation will receive training according to the HBB curriculum with a special module for training on supraglottic airway insertion. Resuscitation will be performed according to international guidelines.

UTILITY OF THE STUDY It is crucial to explore alternative, cost-effective modalities that not only would reduce mortality, but also the burden of neurological damage in survivors.


Options:
A: 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
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: 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: 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

Answer: A