Supraglottic Airway for Neonatal Resuscitation

(SUGAR Trial)

Not yet recruiting at 29 trial locations

Overseen By Chris Bonadfide, MD, MSCE

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Children's Hospital of Philadelphia

Disqualifiers: Congenital diaphragmatic hernia, Airway anomalies

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a device called a supraglottic airway, which aids newborns in breathing during resuscitation. The goal is to determine if early use of this device improves newborn recovery. Two different strategies are being compared to ensure effective use of the device. Hospital staff involved in newborn resuscitation and babies born at 34 weeks or later who need help breathing immediately after birth can participate. Babies with certain medical conditions, such as diaphragm issues or unusual airway structures, are not eligible. As an unphased trial, this study allows participants to contribute to important research that could enhance newborn care practices.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that this supraglottic airway is safe for neonatal resuscitation?

Research has shown that a supraglottic airway, a breathing device placed above the voice box, is safe for newborns needing respiratory assistance. It is easy to use and recommended worldwide when other devices, like face masks, are ineffective. Previous studies have demonstrated its effectiveness in improving newborns' breathing immediately after birth.

These studies indicate that the supraglottic airway is well-tolerated and provides effective breathing support, crucial for newborns requiring assistance. Healthcare providers have safely used the device in many newborns, making it a reliable choice. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using the supraglottic airway for neonatal resuscitation because it offers a potentially more efficient and easier-to-use alternative to traditional methods like bag-mask ventilation and endotracheal intubation. The supraglottic airway is designed to be quickly inserted without the need for deep insertion into the trachea, which can reduce the time needed to establish effective ventilation. This method could simplify the resuscitation process for newborns, especially in emergency situations, and improve outcomes by providing rapid and reliable airway management.

What evidence suggests that the supraglottic airway is effective for neonatal resuscitation?

Studies have shown that certain breathing devices, called supraglottic airways (SGAs), effectively help newborns breathe during emergencies. Research indicates that SGAs can quickly open the airway and assist with breathing. New evidence supports using devices like the laryngeal mask airway (LMA) as the first choice for babies needing breathing assistance. Babies receiving SGAs are also less likely to require intensive care after birth. Overall, SGAs are considered a strong option for aiding newborns' breathing. This trial will compare the effectiveness of the Enhanced Standard of Care with and without SGAs in neonatal resuscitation. ^{1 3 6 7 8}

Who Is on the Research Team?

Elizabeth E Foglia, MD, MSCE

Principal Investigator

Children's Hospital of Philadelphia

Are You a Good Fit for This Trial?

This trial is for newborns requiring resuscitation in the delivery room. It's designed to test if certain methods improve how babies are helped to breathe right after birth. Specific eligibility details aren't provided, but typically participants would be those in need of immediate respiratory support.

Inclusion Criteria

I work full-time in newborn care and speak English fluently.

I manage newborn care at a local or hospital level and speak English fluently.

I work full-time in newborn care and speak English fluently.

Exclusion Criteria

Clinical provider and administrator exclusion 1a criteria: No exclusion criteria

Clinical provider 1b exclusion criteria: No exclusion criteria

I had resuscitation at birth due to a diaphragmatic hernia or airway issues.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implementation Strategy Evaluation

Evaluation of two strategies to promote early supraglottic airway (SA) rescue during neonatal resuscitation

Up to 2 years

Follow-up

Participants are monitored for safety and effectiveness after implementation

Up to 6 months

What Are the Treatments Tested in This Trial?

Interventions

• Supraglottic Airway

Trial Overview The study compares two approaches: 'Enhanced' and 'Enhanced-Plus'. Both aim to better implement the use of a supraglottic airway (SA) device during neonatal resuscitation. The goal is to see which method more effectively helps infants breathe when they can't do it on their own.

How Is the Trial Designed?

Group I: Enhanced Standard of Care Plus Facilitation ("Enhanced-Plus") Active Control 1 Intervention

Group II: Enhanced Standard of Care ("Enhanced") Active Control 1 Intervention

Who Is Running the Clinical Trial?

Children's Hospital of Philadelphia

Lead Sponsor

Trials

749

Recruited

11,400,000+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

Citations

1. nature.com nature.com/articles/s41390-025-04106-w

Supraglottic airway use during neonatal resuscitation At present, the SGA should be regarded as a highly effective device to establish an airway and provide respiratory support, which for most ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10047032/

Time to Effective Ventilation in Neonatal Manikins with a ... Emerging data supports the use of supraglottic airways such as the laryngeal mask airway (LMA) as a first-line interface for PPV during neonatal resuscitation.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT07150923

NCT07150923 | Supraglottic Airway for Resuscitation Trial This trial will assess the comparative effectiveness of two implementation strategies while examining the contextual factors that influence ...

4. research.chop.edu research.chop.edu/cornerstone-blog/implementation-trial-studies-supraglottic-airways-use-for-neonatal-resuscitation

Implementation Trial Studies Supraglottic Airways Use for ... Babies who receive supraglottic airways are also less likely to be admitted to the neonatal intensive care unit (NICU). These results led the ...

5. pcori.org pcori.org/research-results/2024/comparing-two-multicomponent-strategies-promote-supraglottic-airway-implementation-during-neonatal-resuscitation

Comparing Two Multicomponent Strategies To Promote ... This study compares the clinical effectiveness of two strategies to implement supraglottic airway (SA) use during neonatal resuscitation.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6642595/

Neonatal resuscitation using a supraglottic airway device ... Effective ventilation during neonatal resuscitation has the potential to reduce 40% of these deaths. Face-mask ventilation performed by midwives is globally the ...

7. ahajournals.org ahajournals.org/doi/10.1161/CIR.0000000000001363

Neonatal Life Support: 2025 International Liaison ... National data from 2022 to 2023 from Australia indicated that among over 600 000 live-born infants, 10.3% received continuous positive airway ...

8. publications.aap.org publications.aap.org/pediatrics/article/150/3/e2022057567/188755/Supraglottic-Airways-Tennis-and-Neonatal

Supraglottic Airways, Tennis, and Neonatal Resuscitation Inserting a supraglottic airway (SA) shortens the distance to the glottis, improving the success of positive pressure ventilation (PPV). In this ...