Neonatal ResuscitationSUGARNCT07150923
Supraglottic Airway for Resuscitation Trial
A study of Neonatal Resuscitation and Delivery Room Resuscitation, run by Children's Hospital of Philadelphia at 30 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 days and older
- Conditions the study is for
- Neonatal Resuscitation, Delivery Room Resuscitation, Positive Pressure Ventilation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36,503 participants
- Where
- 30 sitesUnited States
- Study dates
- 1 Jan 2026to Sep 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 days and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Congenital diaphragmatic hernia
- Airway anomalies
Trial locations and contacts
30 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Christopher P Bonafide, MD, MSCE contact
30 sites in 1 country
United States30 sites, 30 recruiting
- Not yet recruiting
South Shore University Hospital
Bay Shore, New York, 11706
Naomi Cohen, MD, 212-434-4952, nscohen@northwell.edu
- Recruiting
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Amy Mackay, MD, 205-354-5008, amysessions@uabmc.edu
- Recruiting
Tufts Medical Center
Boston, Massachusetts, 02111
Rachana Singh, MD, MS, 413-847-1144, rsingh2@tuftsmedicalcenter.org
- Recruiting
MaineHealth Mid Coast Hospital
Brunswick, Maine, 04011
Allison Zanno, MD, 203-240-2955, Allison.zanno@mainehealth.org
- Not yet recruiting
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
Jackie Patterson, MD, MPH, 919-608-2853, jackie_patterson@med.unc.edu
- Recruiting
Atrium Health Levine Children's Hospital
Charlotte, North Carolina, 28203
Michelle Chiu, MD, 704-281-8884, Michelle.chiu@atriumhealth.org
- Not yet recruiting
Sharp Chula Vista Medical Center
Chula Vista, California, 91911
Anup Katheria, MD, MS, 858-900-1219, Anup.katheria@sharp.com
- Not yet recruiting
Good Samaritan Hospital
Cincinnati, Ohio, 45220
Morgan Hill, MD, 513-276-1929, Morgan.Hill@cchmc.org
- Not yet recruiting
Nationwide Children's Hospital
Columbus, Ohio, 43205
Cecilie Halling, MD, 469-404-6583, Cecilie.halling@nationwidechildrens.org
- Recruiting
Parkland Health
Dallas, Texas, 75235
Vishal Kapadia, MD, 214-648-3903, Vishal.Kapadia@UTSouthwestern.edu
- Not yet recruiting
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Nicole Spillane, MD, 917-446-6656, nicole.spillane@hmhn.org
- Not yet recruiting
Texas Children's Hospital
Houston, Texas, 77030
Nathan C Sundgren, MD, PhD, 214-770-9142, ncsundgr@texaschildrens.org
- Not yet recruiting
Riley Hospital for Children
Indianapolis, Indiana, 46202
Elizabeth Wetzel, MD, MS, 317-679-0327, wetzelea@iu.edu
- Not yet recruiting
Sharp Grossmont Hospital
La Mesa, California, 91942
Anup Katheria, MD, MS, 858-900-1219, Anup.katheria@sharp.com
- Recruiting
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
Caroline Crocker, DO, 512-656-8045, CECrocker@uams.edu
- Not yet recruiting
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Manoj Biniwale, MD, 424-832-9724, Manoj.biniwale@cshs.org
- Recruiting
Children's Wisconsin
Milwaukee, Wisconsin, 53226
Ruby Gupta, MBBS, MS, 262-312-4577, rgupta@mcw.edu
- Not yet recruiting
Rady Children's NICU at Rancho Springs Medical Center
Murrieta, California, 92562
Richard Song, MD, 773-620-3025, r1song@health.ucsd.edu
- Not yet recruiting
Lenox Hill Hospital
New York, New York, 10075
Naomi Cohen, MD, 212-434-4952, nscohen@northwell.edu
- Recruiting
ChristianaCare
Newark, Delaware, 19718
Michael Favara, DO, 302-932-4359, mfavara@christianacare.org
- Not yet recruiting
Oklahoma Children's Hospital
Oklahoma City, Oklahoma, 73104
Birju A Shah, MD, MBA, MPH, 201-496-8383, birju-shah@ouhsc.edu
- Recruiting
Lucile Packard Children's Hospital
Palo Alto, California, 94304
Arun Gupta, MD, 650-248-4570, agup@stanford.edu
- Recruiting
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Heidi Herrick, MD, MS, 267-408-6146, herrickh@chop.edu
- Recruiting
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19146
Elizabeth E Foglia, MD, MSCE, 267-441-7144, foglia@chop.edu
- Recruiting
MaineHealth Maine Medical Center
Portland, Maine, 04102
Allison Zanno, MD, 203-240-2955, Allison.zanno@mainehealth.org
- Not yet recruiting
Cohen Children's Medical Center
Queens, New York, 11040
Naomi Cohen, MD, 212-434-4952, nscohen@northwell.edu
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
Jane Brumbaugh, MD, 651-260-5035, Brumbaugh.Jane@mayo.edu
- Not yet recruiting
Jacobs Medical Center at University of California San Diego Health
San Diego, California, 92037
Pamela Del Rosario, MD, 858-249-1702, pdelrosario@health.ucsd.edu
- Not yet recruiting
Sharp Mary Birch Hospital for Women & Newborns
San Diego, California, 92123
Anup Katheria, MD, 858-900-1219, Anup.katheria@sharp.com
- Not yet recruiting
St. John's Children's Hospital
Springfield, Illinois, 62701
Mohamed F Ahamed, MD, 917-969-1981, mahamed52@siumed.edu
About this study
Official title: Comparing Two Multicomponent Strategies To Promote Supraglottic Airway Implementation During Neonatal Resuscitation
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.
Read the 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.
- Conditions
- Neonatal Resuscitation, Delivery Room Resuscitation, Positive Pressure Ventilation, Infant, Newborn, Supraglottic Airway, Laryngeal Mask Airways
- Being tested
- Enhanced Standard of Care ("Enhanced"), Enhanced Standard of Care ("Enhanced-Plus")
- Keywords
- Neonatal Resuscitation, Delivery Room Resuscitation, Positive pressure ventilation, Supraglottic Airway, Laryngeal Mask Airways, Implementation Research, Infant, Newborn
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Enhanced Standard of Care ("Enhanced") | Active comparator | Not described Receives: Other: Enhanced Standard of Care ("Enhanced") |
| Enhanced Standard of Care Plus Facilitation ("Enhanced-Plus") | Active comparator | Not described Receives: Other: Enhanced Standard of Care ("Enhanced-Plus") |
What is being measured
The primary outcome is the main question the study is designed to answer.
Penetration of early SA rescue
Proportion of eligible patients treated with SA as an early rescue device. Excludes SA after intubation attempt.
Measured: Up to 2 years
Secondary outcomes (2)
Initial adoption of early SA rescue
Quarters required to reach 10% penetration of SA use among eligible patients at hospital level
Measured: 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.
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2025
- Study start1 Jan 2026
- Primary completionSep 2028 (estimated)
- Study completionSep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal ResuscitationStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Hybrid type 3 effectiveness-implementation parallel cluster randomized superiority trial
- Masking
- None (open label)
- Enrolment
- 36,503 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Sponsor
- Investigators
- Elizabeth E Foglia, MD, MSCE, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07150923
- Sponsor's protocol ID
- 24-022884
- Other IDs
- 33954
- Acronym
- SUGAR
- Status last verified
- Feb 2026
- First submitted
- 27 Aug 2025
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Two Multicomponent Strategies To Promote Supraglottic Airway Implementation During Neonatal Resuscitation
- ClinicalTrials.gov ID
- NCT07150923
- Acronym / sponsor ID
- SUGAR / 24-022884
- Conditions
- Neonatal Resuscitation, Delivery Room Resuscitation, Positive Pressure Ventilation, Infant, Newborn, Supraglottic Airway, Laryngeal Mask Airways
- Keywords
- Neonatal Resuscitation, Delivery Room Resuscitation, Positive pressure ventilation, Supraglottic Airway, Laryngeal Mask Airways, Implementation Research, Infant, Newborn
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36,503 participants (estimated)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Sep 2029 (estimated)
- First posted
- 2 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Hybrid type 3 effectiveness-implementation parallel cluster randomized superiority trial
| Arm | Type | Receives |
|---|---|---|
| Enhanced Standard of Care ("Enhanced") | Active comparator | Other: Enhanced Standard of Care ("Enhanced") |
| Enhanced Standard of Care Plus Facilitation ("Enhanced-Plus") | Active comparator | Other: Enhanced Standard of Care ("Enhanced-Plus") |
Who may qualify
- Ages
- 0 days and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (2 listed)
- Congenital diaphragmatic hernia
- Airway anomalies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Enhanced Standard of Care ("Enhanced") |
| 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. | Other | Enhanced Standard of Care Plus Facilitation ("Enhanced-Plus") |
Primary outcome
Penetration of early SA rescue
Time frame: Up to 2 years
Proportion of eligible patients treated with SA as an early rescue device. Excludes SA after intubation attempt.
2 secondary outcomes
Initial adoption of early SA rescue
Time frame: Up to 2 years
Sustainment of early SA rescue
Time frame: Up to 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: No
Related trials for Neonatal Resuscitation
Recruiting
The Periviable GOALS Decision Support Tool
Pregnancy Preterm, Premature Birth
Recruiting
Sustained Cord Circulation at Emergency Cesarean Section
Asphyxia Neonatorum, Fetal Hypoxia
Not yet recruiting
Sustained Inflation and Chest Compression vs 3:1 C:V Ratio in Asphyxiated Newborns
Cardiac Arrest
Enrolling by invitationObservational study
Cryo-FIRST: Effectiveness of INTERCEPT Fibrinogen Complex (IFC) for Trauma-Associated Hemorrhage
Hypofibrinogenemia, Hemorrhage
Recruiting
Video-Based Self-Assessment in Neonatal Resuscitation Training
Neonatal Resuscitation, Simulation-Based Education
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christopher P Bonafide, MD, MSCE contact
Elizabeth E Foglia, MD, MSCE principal investigator
Children's Hospital of Philadelphia
30 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Neonatal Resuscitation and Delivery Room Resuscitation, run by Children's Hospital of Philadelphia at 30 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elizabeth E Foglia, MD, MSCE (215-590-1653, foglia@chop.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Penetration of early SA rescue (time frame: Up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.