Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
36503 participants
INTERVENTIONAL
2026-01-31
2029-09-30
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Enhanced Standard of Care ("Enhanced")
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.
Enhanced Standard of Care Plus Facilitation ("Enhanced-Plus")
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* Fluent in English
* 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
* Employed full-time by the hospital, affiliated practice, or affiliated university in a role that involves newborn resuscitation
* Fluent in English
* 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
Population 2: Patients who receive neonatal resuscitation at birth
* Congenital diaphragmatic hernia
* Airway anomalies
0 Days
ALL
No
Sponsors
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Patient-Centered Outcomes Research Institute
OTHER
Children's Hospital of Philadelphia
OTHER
Responsible Party
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Principal Investigators
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Elizabeth E Foglia, MD, MSCE
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital of Philadelphia
Locations
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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
St. John's Children's Hospital
Springfield, Illinois, United States
Riley Hospital for Children
Indianapolis, Indiana, United States
MaineHealth Mid Coast Hospital
Brunswick, Maine, United States
MaineHealth Maine Medical Center
Portland, Maine, United States
Tufts Medical Center
Boston, Massachusetts, United States
Mayo Clinic
Rochester, Minnesota, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
South Shore University Hospital
Bay Shore, New York, United States
Lenox Hill Hospital
New York, New York, United States
Cohen Children's Medical Center
Queens, New York, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Atrium Health Levine Children's Hospital
Charlotte, North Carolina, United States
Good Samaritan Hospital
Cincinnati, Ohio, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
Oklahoma Children's Hospital
Oklahoma City, Oklahoma, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Parkland Health
Dallas, Texas, United States
Texas Children's Hospital
Houston, Texas, United States
Children's Wisconsin
Milwaukee, Wisconsin, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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33954
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
24-022884
Identifier Type: -
Identifier Source: org_study_id
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