Supraglottic Airway for Resuscitation Trial

Children's Hospital of Philadelphia36,503 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Interventions

Enhanced Standard of Care ("Enhanced")OTHER

Enhanced Standard of Care ("Enhanced") will include: Educational Materials and Outreach, Local Champions, Train the Trainer, Local Simulation Training, and SA Starter Packs.

Enhanced Standard of Care ("Enhanced-Plus")OTHER

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.

Eligibility

Sex: ALLMin age: 0 Days

Medical Language ↔ Plain English

Population 1: Hospital Staff Population 1a: Clinical providers and administrators who complete study questionnaires Clinical provider 1a inclusion criteria: * Employed full-time by the hospital, affiliated practice, or affiliated university in a role that involves newborn resuscitation * Fluent in English Administrator 1a inclusion criteria * Oversee the care of newborns on a local level (e.g. nurse manager) or a hospital level (e.g. Chief Quality and Safety Officer) * Fluent in English Clinical provider and administrator exclusion 1a criteria: No exclusion criteria Population 1b: Clinical providers who participate in qualitative interviews Clinical provider 1b inclusion criteria: * Employed full-time by the hospital, affiliated practice, or affiliated university in a role that involves newborn resuscitation * Fluent in English Clinical provider 1b exclusion criteria: No exclusion criteria Population 2: Patients who receive neonatal resuscitation at birth 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

Locations (30)

University of Alabama at Birmingham

Birmingham, Alabama, United States

RECRUITING

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

RECRUITING

Sharp Chula Vista Medical Center

Chula Vista, California, United States

NOT_YET_RECRUITING

Sharp Grossmont Hospital

La Mesa, California, United States

Outcomes

Primary Outcomes

Penetration of early SA rescue

Proportion of eligible patients treated with SA as an early rescue device. Excludes SA after intubation attempt.

Time frame: Up to 2 years

Secondary Outcomes

Initial adoption of early SA rescue

Quarters required to reach 10% penetration of SA use among eligible patients at hospital level

Time frame: Up to 2 years

Sustainment of early SA rescue

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.

Time frame: Up to 1 year