Supraglottic Airway for Resuscitation Trial
SUGAR
Comparing Two Multicomponent Strategies To Promote Supraglottic Airway Implementation During Neonatal Resuscitation
2 other identifiers
interventional
36,503
1 country
30
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2026
Longer than P75 for not_applicable
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 27, 2025
CompletedFirst Posted
Study publicly available on registry
September 2, 2025
CompletedStudy Start
First participant enrolled
January 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2029
February 27, 2026
February 1, 2026
2.7 years
August 27, 2025
February 26, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Penetration of early SA rescue
Proportion of eligible patients treated with SA as an early rescue device. Excludes SA after intubation attempt.
Up to 2 years
Secondary Outcomes (2)
Initial adoption of early SA rescue
Up to 2 years
Sustainment of early SA rescue
Up to 1 year
Other Outcomes (5)
Neonatal Intensive Care Unit (NICU) Admission
Up to 30 days of life
Hypoxic Ischemic Encephalopathy (HIE)
Up to 30 days of life
Any exposure to Endotracheal Tube
Up to 30 days of life
- +2 more other outcomes
Study Arms (2)
Enhanced Standard of Care ("Enhanced")
ACTIVE COMPARATOREnhanced Standard of Care Plus Facilitation ("Enhanced-Plus")
ACTIVE COMPARATORInterventions
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") 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
You may qualify if:
- Employed full-time by the hospital, affiliated practice, or affiliated university in a role that involves newborn resuscitation
- 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
You may not qualify if:
- Population 1b: Clinical providers who participate in qualitative interviews
- Employed full-time by the hospital, affiliated practice, or affiliated university in a role that involves newborn resuscitation
- Fluent in English
- Population 2: Patients who receive neonatal resuscitation at birth
- 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)
- Congenital diaphragmatic hernia
- Airway anomalies
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (30)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205, United States
Sharp Chula Vista Medical Center
Chula Vista, California, 91911, United States
Sharp Grossmont Hospital
La Mesa, California, 91942, United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
Rady Children's NICU at Rancho Springs Medical Center
Murrieta, California, 92562, United States
Lucile Packard Children's Hospital
Palo Alto, California, 94304, United States
Jacobs Medical Center at University of California San Diego Health
San Diego, California, 92037, United States
Sharp Mary Birch Hospital for Women & Newborns
San Diego, California, 92123, United States
ChristianaCare
Newark, Delaware, 19718, United States
St. John's Children's Hospital
Springfield, Illinois, 62701, United States
Riley Hospital for Children
Indianapolis, Indiana, 46202, United States
MaineHealth Mid Coast Hospital
Brunswick, Maine, 04011, United States
MaineHealth Maine Medical Center
Portland, Maine, 04102, United States
Tufts Medical Center
Boston, Massachusetts, 02111, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
South Shore University Hospital
Bay Shore, New York, 11706, United States
Lenox Hill Hospital
New York, New York, 10075, United States
Cohen Children's Medical Center
Queens, New York, 11040, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599, United States
Atrium Health Levine Children's Hospital
Charlotte, North Carolina, 28203, United States
Good Samaritan Hospital
Cincinnati, Ohio, 45220, United States
Nationwide Children's Hospital
Columbus, Ohio, 43205, United States
Oklahoma Children's Hospital
Oklahoma City, Oklahoma, 73104, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19146, United States
Parkland Health
Dallas, Texas, 75235, United States
Texas Children's Hospital
Houston, Texas, 77030, United States
Children's Wisconsin
Milwaukee, Wisconsin, 53226, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Elizabeth E Foglia, MD, MSCE
Children's Hospital of Philadelphia
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 27, 2025
First Posted
September 2, 2025
Study Start
January 1, 2026
Primary Completion (Estimated)
September 1, 2028
Study Completion (Estimated)
September 1, 2029
Last Updated
February 27, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share