NCT07150923

Supraglottic Airway for Resuscitation Trial

Comparing Two Multicomponent Strategies To Promote Supraglottic Airway Implementation During Neonatal Resuscitation

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 36,503 (estimated)
• Sponsor: Children's Hospital of Philadelphia · Academic / Other
• Sex: All
• Age: 0 Days
• Healthy volunteers: Not accepted

Summary

This is a hybrid type 3 effectiveness-implementation parallel cluster randomized superiority trial designed to compare two strategies to promote early supraglottic airway (SA) rescue during neonatal resuscitation, with a focus on implementation outcomes.

Detailed description

Each year, approximately 3.8 million infants are born in the United States, and up to 10% require resuscitation to establish breathing at birth. Positive pressure ventilation (PPV) is the most important intervention during neonatal resuscitation and is most often delivered via facemask. However, facemask ventilation can be technically challenging, and difficulties with mask seal, airway positioning, and obstruction frequently lead to ventilation failure. Such delays prolong life-threatening asphyxia and increase the risk of morbidity and mortality. The supraglottic airway (SA) is an FDA-approved, widely available, and evidence-based alternative airway device for delivering PPV. It is safe, easy to use, and recommended in international neonatal resuscitation guidelines as an option when facemask ventilation is ineffective or endotracheal intubation is unsuccessful or not feasible. Despite strong supporting evidence, uptake of SA use in neonatal resuscitation remains low. A recent national survey of more than 5,000 Neonatal Resuscitation Program (NRP) providers found that only 12% had ever used an SA. Reported barriers to adoption included limited clinical experience, insufficient training opportunities, preference for alternative approaches, lack of availability of SA devices in the delivery room, and limited awareness of supporting evidence. The Supraglottic Airway for Resuscitation (SUGAR) Trial is designed to address the critical evidence-to-practice gap by evaluating strategies to increase the use of supraglottic airways (SA) during neonatal resuscitation. This trial will assess the comparative effectiveness of two implementation strategies while examining the contextual factors that influence their success, with the goal of identifying barriers and facilitators to sustainable SA adoption across diverse clinical settings. By testing approaches to integrate SA use into routine neonatal resuscitation, the study aims to improve both implementation and clinical outcomes, ultimately reducing the risk of prolonged asphyxia and enhancing survival and health for newborns in the delivery room.

Conditions

• Neonatal Resuscitation
• Delivery Room Resuscitation
• Positive Pressure Ventilation
• Infant, Newborn
• Supraglottic Airway
• Laryngeal Mask Airways
• Implementation Research

Interventions

Type	Name	Description
OTHER	Enhanced Standard of Care ("Enhanced")	Enhanced Standard of Care ("Enhanced") will include: Educational Materials and Outreach, Local Champions, Train the Trainer, Local Simulation Training, and SA Starter Packs.
OTHER	Enhanced Standard of Care ("Enhanced-Plus")	Enhanced Standard of Care ("Enhanced-Plus") will include: Educational Materials and Outreach, Local Champions, Train the Trainer, Local Simulation Training, SA Starter Packs, and three additional intensive external facilitation components.

Timeline

• Start date: 2026-01-01
• Primary completion: 2028-09-01
• Completion: 2029-09-01
• First posted: 2025-09-02
• Last updated: 2026-02-27

Locations

30 sites across 1 country: United States