Supraglottic Airway for Resuscitation Trial

Not Applicable

Not yet recruiting

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

• Registration Number: NCT07150923
• Lead Sponsor: Children's Hospital of Philadelphia

Brief 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.

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-27
• Study First Submitted QC: 2025-08-27
• Last Update Submitted: 2025-08-27
• Study First Posted: 2025-09-02
• Last Update Posted: 2025-09-02
• Study Start: 2026-01-01
• Primary Completion: 2028-09
• Study Completion: 2029-09-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 36503

Inclusion Criteria

• Inborn (not transferred to the hospital after birth)
• ≥34 weeks' gestation at birth, based on best obstetrical estimate
• Received PPV during neonatal resuscitation (as per provider's clinical assessment)

Exclusion Criteria

• Congenital diaphragmatic hernia
• Airway anomalies

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Penetration of early SA rescue	Up to 2 years	Proportion of eligible patients treated with SA as an early rescue device. Excludes SA after intubation attempt.

Secondary Outcome Measures

Name	Time	Method
Initial adoption of early SA rescue	Up to 2 years	Quarters required to reach 10% penetration of SA use among eligible patients at hospital level
Sustainment of early SA rescue	Up to 1 year	Proportion of SA use among eligible patients per quarter examined using linear mixed effects model to quantitatively assess successful sustainment (slope of penetration proportion positive or not significantly different than 0) versus decay (slope of penetration negative) post-implementation.

Trial Locations

Locations (30)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

University of Arkansas for Medical Sciences; 🇺🇸 Little Rock, Arkansas, United States

Sharp Chula Vista Medical Center; 🇺🇸 Chula Vista, California, United States

Sharp Grossmont Hospital; 🇺🇸 La Mesa, California, United States

Cedars-Sinai Medical Center; 🇺🇸 Los Angeles, California, United States

Rady Children's NICU at Rancho Springs Medical Center; 🇺🇸 Murrieta, California, United States

Lucile Packard Children's Hospital; 🇺🇸 Palo Alto, California, United States

Jacobs Medical Center at University of California San Diego Health; 🇺🇸 San Diego, California, United States

Sharp Mary Birch Hospital for Women & Newborns; 🇺🇸 San Diego, California, United States

ChristianaCare; 🇺🇸 Newark, Delaware, United States

Scroll for more (20 remaining)