Supraglottic Airway for Resuscitation Trial (SUGAR)

Children's Hospital of Philadelphia (CHOP)

Status: Enrolling

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

Treatments: Other: Enhanced Standard of Care ("Enhanced-Plus"); Other: Enhanced Standard of Care ("Enhanced")

Study type: Interventional

Funder types: Other

Identifiers

NCT07150923

24-022884

33954 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36,503 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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36,503 participants in 2 patient groups

Enhanced Standard of Care ("Enhanced")

Active Comparator group

Treatment:

Other: Enhanced Standard of Care ("Enhanced")

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

Active Comparator group

Treatment:

Other: Enhanced Standard of Care ("Enhanced-Plus")